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NCT ID: NCT04129164 Completed - Sjögren's Syndrome Clinical Trials

A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome

SS
Start date: October 16, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).

NCT ID: NCT04128696 Terminated - Clinical trials for Neoplasms, Head and Neck

Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

INDUCE-3
Start date: November 21, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) >=1 R/M HNSCC.

NCT ID: NCT04127994 Recruiting - Clinical trials for Overweight and Obesity

Glycemic Variability Comparing Two vs Six Meals in Type 2 Diabetes

Start date: August 17, 2018
Phase: N/A
Study type: Interventional

The frequency of meals is a very important aspect of nutrition, with profound effects on human health and in life expectancy. Excessive energy consumption is totally associated with a significant increase in the incidence of chronic diseases including diabetes. That is why nutritional therapy is recommended for all people with diabetes mellitus type 1 and 2 as an effective complement to your medical treatment. For overweight or obese type 2 diabetic patients, a low-calorie diet along with healthy eating patterns are recommended for weight loss. Similarly, modest body weight decrease may provide clinical benefits in patients, such as improved blood glucose, blood pressure, lipid profile, and others. Data about the role of nutritional habits and energy density being important precursors of obesity and diabetes are well known. On the other hand, data regarding frequency and timing of meals and how these factors relate to corporal weight are not totally understood.

NCT ID: NCT04126200 Recruiting - Multiple Myeloma Clinical Trials

Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

DREAMM5
Start date: October 7, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.

NCT ID: NCT04123366 Active, not recruiting - Solid Tumors Clinical Trials

Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)

Start date: November 18, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.

NCT ID: NCT04119843 Completed - Clinical trials for Severe Renal Impairment

Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function

SPARKLE
Start date: February 19, 2020
Phase: Phase 3
Study type: Interventional

The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.

NCT ID: NCT04115904 Enrolling by invitation - Pain, Postoperative Clinical Trials

Acute Pain Rate of Single Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulps

Acute pain
Start date: February 8, 2018
Phase: Phase 2
Study type: Interventional

Aim to compare acute pain rate after single-visit ortwo-visits treatment of teeth with necrotic pulp and apical periodontitis .90 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex.Working length was established with EAL and confirmed radiographically. Flex-R files were used to complete canal preparation. Level ofdiscomfort were recorded and cases with acute postoperative pain.

NCT ID: NCT04115800 Completed - Dry Eye Clinical Trials

Liposomal Sirolimus in Dry Eye Disease

Start date: October 2, 2019
Phase: Early Phase 1
Study type: Interventional

Dry eye disease is a very frequent pathology that importantly affects the quality of life of patients; in spite of the common use of eye lubricants to ameliorate symptoms, there is still a large number of patients who do not present improvement of the disease or they worsen. Although its etiology is varied, the imbalance of the immune system plays a substantial role in the development of dry eye disease. Rapamycin or sirolimus is an anti-inflammatory and immunomodulatory drug that has an enormous potential in ocular surface pathologies such as dry eye disease. The aim of the present study is to determine the effectiveness and security of subconjunctival application of a new formulated drug of liposomal sirolimus in patients with moderate and severe dry eye disease. This is a randomized placebo-controlled double blind clinical trial. Patients presenting data of moderate or severe dry eye disease will be randomized into two groups. One group will receive additional to the conventional treatment, subconjunctival injections of liposomal sirolimus; meanwhile the other group will receive subconjunctival placebo injections. After intervention the effectiveness and the security of the liposomal sirolimus will be evaluated.

NCT ID: NCT04111965 Completed - Dry Eye Clinical Trials

Clinical Trial to Compare the Safety and Efficacy of Nanodrop®

PRO-176/I
Start date: December 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Study design: Phase I-II clinical trial, comparative, non-inferiority with active control, parallel groups, double blind with randomisation. Safety analysis when completing the visits of the first 12 subjects of the Nanodrop® group, if there are less than 20% of unexpected Events (EA), related to the research product, recruitment is continued until the sample is completed for efficacy analysis objectives Security: Evaluate the safety of the ophthalmic application of Nanodrop® by quantifying the incidence of unexpected Adverse Events (EA) related to the research product (PI). Effectiveness: Demonstrate the non-inferiority of Nanodrop® compared to Systane® Balance, in the efficacy of the treatment of patients with dry eye, by means of the Ocular Surface Disease Index (OSDI). Hypothesis Security: H0 = Nanodrop® is safe in its ophthalmic application as it presents an incidence of unexpected adverse events related to the research drug, less than 20% of the population of Nanodrop® safety group. H1 = Nanodrop® is not safe in its ophthalmic application, as it presents an incidence of unexpected adverse events related to the research drug, exceeding 20% of the population of Nanodrop® safety group. Effectiveness: H0 = Nanodrop® is lower than Systane® Balance by more than 5 points in the OSDI test score. H1 = Nanodrop® is lower than Systane® Balance by 5 points or less in the OSDI test score. Number of subjects: n = 126 evaluable subjects 63 evaluable subjects per group (both eyes). Main inclusion criteria: Dry eye diagnosis Duration of intervention treatment: 28 days Approximate duration of the subject in the study: 35 days

NCT ID: NCT04110392 Completed - Dyslipidemias Clinical Trials

Effect of Consumption of Chaya on Lipid Concentration and Antioxidant Status of Patients With Dyslipidemia

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Currently, the changes generated in lifestyle, such as excessive consumption of saturated fats and refined carbohydrates, as well as the decrease in the intake of fiber, fruits, vegetables and antioxidants, as well as physical inactivity, have generated an increase in the prevalence of dyslipidemias. Dyslipidemias are a disorder of blood lipid and lipoprotein concentration, which increases the risk of developing atherosclerosis and cardiovascular diseases. In Mexico, the dyslipidemias are present in one in four Mexicans over 20 years old. However, in Yucatan increases this frequency increases due to one in three people suffer from dyslipidemia. Its prevalence is even higher in overweight subjects, diabetes and high blood pressure. Thus, it is important to search for strategies to reduce dyslipidemias, as well as the complications associated with them. The treatment and prevention of dyslipidemia is through dietary treatment, which may be accompanied by the consumption of foods that generate beneficial health effects due to the presence of bioactive compounds. Chaya (Cnidoscolus chayamansa) is a plant use in popular medicine to treat medicine in the treatment of chronic degenerative diseases. It contained different bioactive compounds such as flavonoids, vitamin C and polyphenols such as quercetin and kaempferol. Compounds that have been assigned various beneficial effects such as decreased triglyceride concentrations, cholesterol, malondialdehyde, C-Reactive protein, oxidized LDL, which are alterations that are present in dyslipidemia. Therefore, the consumption of this food could be an adequate strategy for subjects with dyslipidemia in Yucatan and Mexico due to the anti-inflammatory and antioxidant effects, and could reduce the risk of developing atherosclerosis and cardiovascular diseases.