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Filter by:Standard treatment for vitiligo often has unsatisfactory outcomes. With a new understanding of pathogenesis, novel drugs have been introduced which have shown to be effective in small-scale studies. Tofacitinib, a Janus kinase(JAK) inhibitor-2 has shown promising results in the treatment of vitiligo. However, randomized controlled studies are required to confirm these observations and identify the patients most likely to benefit from JAK-2 inhibition. This open-labeled randomized clinical trial will be conducted at the department of dermatology and venereology of US Bangla Medical College & Hospital in Dhaka for 6 months duration from June 2021 to November 2021 to Vitiligo patients attending in the aforementioned department will be approached for inclusion in the study. Finally, 80 patients who will fulfill the inclusion and exclusion criteria will be included. All patients will be informed about the nature of the study and the written consent will be taken in the consent form with the assurance that their information will be made confidential. Baseline information such as gender, age, disease history, and drugs used prior will be collected. All patients will undergo baseline laboratory evaluation which will be repeated at 6weeks and 12weeks. Before the beginning of treatment, digital images of the cutaneous lesions will be taken which will be compared with the ones taken at 6weeks and the end of 12weeks follow up. The participants will undergo randomization into 1:1 ratio into two equal groups. Group A will receive oral Tofacitinib and Group B will receive topical 0.1%Mometasone furoate. All the participants will receive allotted intervention for 12weeks. The patient will be followed up at 6 weeks and end of 12 weeks. The primary outcome of the study will be the improvement of the Vitiligo Area Scoring Index (VASI) score at 6 and12 weeks in all groups. Secondary outcomes will include improvement in Vitiligo European Task Force (VETF) scoring. The data will be systematically described and summarized and presented through descriptive statistics and finally will be analyzed by the statistical program Statistical Package for Social Science (SPSS) version 23.0(Chicago, Illinois, USA). The relevant statistical test will be used during the analysis. In all cases, the significance level will set p <0.05. Ethical clearance of the study will be obtained from the ethical review committee (ERC) of the study place.
Apatinib has led to positive responses in the treatment of osteosarcoma refractory to first-line chemotherapy. However, apatinib demonstrates only short-lived activity, and the disease control of musculoskeletal lesions is worse than that of pulmonary lesions. This treatment failure has been partly overcome by the addition of ifosfamide and etoposide (IE). We have ever retrospectively compared the activity of apatinib + IE in relapsed or refractory osteosarcoma in two sarcoma centers in China and concluded that for osteosarcoma with multiple sites of metastasis, apatinib + IE demonstrated clinically meaningful antitumor activity and delayed disease progression in patients with recurrent or refractory osteosarcoma after failure of chemotherapy. However to overcome the influence of other interventions on the outcome, we are currently performing a prospective trial to investigate this combination, from which more accurate data on this treatment strategy are expected.
Pembrolizumab monotherapy and platinum-based chemotherapy in the combination with pembrolizumab for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) have been widely used in daily clinical practice based on the KEYNOTE-048 study. On the other hand, docetaxel is a commonly used antimitotic agent in cancer therapy and might have potent antitumor effect by the immune response. A combination therapy of docetaxel and pembrolizumab might be a promising treatment for R/M HNSCC. The KEYNOTE-048 study showed that pembrolizumab plus platinum and 5-fluorouracil is a tolerable treatment for R/M HNSCC. The main grade 3/4 adverse event of platinum and 5-fluorouracil was myelosuppression such as neutropenia similar to docetaxel in some studies for R/M HNSCC. The safety profile of platinum and 5-fluorouracil is not much different from docetaxel. Therefore, docetaxel/pembrolizumab combination treatment might also be tolerable. The hypothesis of this study is that a combination therapy of docetaxel and pembrolizumab will provide benefit for patients with R/M HNSCC.
Using a double-blind, randomized, placebo-controlled design to compare the immediate, short-term, and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection to hyaluronic acid injection on patients with knee osteoarthritis, under the basis of International Classification of Functioning, Disability and Health.
In recent years, mitochondrial dysfunction and oxidative stress have been implicated in PD pathophysiology. Intermittent hypoxia therapy (IHT) is an upcoming treatment used by elite athletes as well as fragile individuals in clinical settings that works by improving exercise tolerance, neuroplasticity and inducing hypoxic preconditioning (HPC). HPC might improve the oxidative stress response in PD on the long-term. In addition, preclinical evidence suggests beneficial short-term effects such as influence on dopamine and noradrenalin release. Anecdotal evidence indeed suggests that visiting high-altitude areas improves PD symptoms and it is hypothesized that this effect results from decreased oxygen pressure at high altitudes. The safety and feasibility of (intermittent) hypoxia therapy on PD symptoms will be assessed in an exploratory phase I randomized-controlled trial.
Fucoidans are fucose-rich sulfated carbohydrates found in brown marine algae and have been shown to play a role in immune modulation as well as inflammation. In fact, fucoidans have been shown to inhibit neutrophil infiltration and attenuate levels of pro-inflammatory cytokines. More research is warranted to determine the effects of supplementation with fucoidans to reduce inflammation following high-intensity exercise. Therefore, this double-blinded, randomized, placebo-controlled, cross-over design study will be conducted to further understand these effects.
Objective: To evaluate the safety and efficacy of Human Insulin rDNA (Insuget) in patients with Type II Diabetes Mellitus. Study Design: Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study. Sample size: The estimated target sample size is n=230. Study duration: 12 months (data lock point will be completion of 6 months' follow-up from the time of last patient's enrollment date) After recruitment, patient is supposed to have three visits for follow-ups. Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy. - Primary (SAFETY Outcomes): - Frequency of adverse events during the course of study follow-up. - Frequency of serious adverse events. - SECONDARY OUTCOME MEASURES (EFFICACY ENDPOINTS) - Change from baseline in HbA1c% to the last-observation. - Change from baseline in fasting plasma glucose to the last- observation on treatment Ethical consideration: The ethical approval of study is taken from an independent ethics committee. The study will be conducted in compliance with the protocol, good clinical practices (GCP), the ethical principles that have their origin in the Declaration of Helsinki and the applicable regulatory requirements.
Dose escalation of ORIN1001 in patients with advanced solid tumors. Dose escalation of ORIN1001 in combination with standard of care in patients with esophageal carcinoma, metastatic breast cancer, hepatocellular carcinoma, metastatic prostate cancer, pancreatic cancer, ovarian cancer and non-small cell lung cancer. Dose expansion of ORIN1001 as a single agent or in combination with standard of care in patients with advanced solid tumors.
Impaction of mandibular third molars is a commonly encountered problem in oral surgery; patients frequently visit dental OPDs with complains related to the impacted molars, and in almost all situations, surgical removal of these impactions is the definitive treatment provided to such patients. This type of surgery often involves osteotomies and tooth sectioning, that initiates acute inflammatory responses which results in significant amount of postoperative discomfort owing to the associated pain, swelling and trismus; which considerably affects the quality of life that may span from days up to weeks in few instances. In the past decades, different group of medications have been used to counter these adverse postoperative sequelae, such as steroidal anti-inflammatory drugs (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs). MATERIAL AND METHODS: Study design: Randomized, double-blind, clinical trial with a split-mouth design. Setting: The study would be conducted at Oral & Maxillofacial Surgery department, Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences, Karachi. Duration of study: Six months after the approval of synopsis. Sample size: A total of 170 patients would be included in the study, i.e. 85 in each group with 2 patients as a drop out. Calculated sample size is 83 patients per group; utilizing Pass version 11 software with 95% confidence interval, mean ± S.D of swelling in dexamethasone group1 95.7 ± 11.1 and in etoricoxib group1 100.0 ± 8.3 at measurement 5. Sampling technique: Purposive non-probability sampling technique would be used for the selection of patients. Sample selection: Patients meeting the following criteria would be included in the study: 1. Age 18-35 years. 2. Absence of any systemic disease. 3. Mandibular third molars in similar position with similar root formation. 3. No use of any medication in last 03 days. 4. Absence of allergy to any drug used in the study. 5. Surgical site with no current signs or symptoms of infection. Patients meeting any of the following criteria would be excluded from the study: 1. Pregnancy or lactation. 2. History of gastrointestinal bleeding or peptic ulcer. 3. Current smoking habit.
The investigators aim to assess the effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for 12 weeks in hepatitis C virus (HCV)-infected patients who fail to prior NS5A-containing DAA regimens and HCV genotype 1a and 3 patients who fail to prior non-NS5A-containing DAA regimen in Taiwan on a basis of a multicenter observational study.