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NCT ID: NCT03635983 Completed - Melanoma Clinical Trials

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Start date: September 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

NCT ID: NCT03635242 Completed - Clinical trials for Chronic Low Back Pain

Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Healed Patients

Start date: June 8, 2018
Phase: N/A
Study type: Interventional

Pretending with the use of accelerometers and pressure platform, determine indicators that are useful to therapists to assess postural control and balance, to subsequently allow to evaluate the effect of therapeutic interventions through therapeutic exercise of motor control in patients with chronic low back pain .

NCT ID: NCT03634943 Completed - Critical Illness Clinical Trials

Evaluation of Nutritional Practices in the Critical Care

ENPIC
Start date: April 23, 2018
Phase:
Study type: Observational

Background: The adequacy of the artificial Nutritional Support (NS) in the critical care patient has implications in morbidity and prognosis. Clinical practice guidelines (CPG) are an important tool for healthcare professionals in their daily practice and a method of consultation for the correct treatment of patients. Also, the evidence remains low and there are important controversies regarding the NS in the critical care patient. Hypothesis: The NS generates great controversy in the professionals involved in the care of critical care patients due to the contradictory results in literature. Despite this, the CPG should serve to standardize the treatment of patients and provide a better adherence to current knowledge in this setting. The importance of NS is underestimated and there is a need to perform proper evaluation of the impact of nutrition. Objectives: To evaluate and analyze NS practices in critically ill patients in different ICUs and assess the adherence to CPGs. To evaluate the relationship of nutrition and outcomes in the ICU. Methodology: Prospective multicenter observational study. Collection of variables from different participating ICUs and the characteristics of the NS of the different admitted patients. Monitoring of nutritional practices and complications. Evaluation of outcomes (e.g. mortality, ICU complications, etc.) with NS. Expected results: Better understanding of the NS and its impact on morbidity and mortality; development of strategies to reduce low adherence to CPGs, improving the quality of care associated with this field in critical care patients; obtain clinical information that will serve as a basis for conducting intervention studies.

NCT ID: NCT03633617 Completed - Clinical trials for Eosinophilic Esophagitis

Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

Start date: September 24, 2018
Phase: Phase 3
Study type: Interventional

The primary objectives of the study by study part are: Part A: To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size determination for Part B. Part B: To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures. Part C: To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures. The secondary objectives of the study are: - To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE - To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses - To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation - To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids

NCT ID: NCT03633292 Completed - Oral Ulcer Clinical Trials

Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers

Start date: January 2015
Phase: Phase 4
Study type: Interventional

The development of gingivitis in patients during orthodontic treatment is widely known, with the characteristic response of gingival inflammation and hyperplasia and traumatic rashes or ulcerations of the oral mucosa derived from the treatment. The use of chemical agents such as CHX, although it has proven to be useful in these patients, but has the disadvantage of having side effects such as staining, even restricting its use during treatment. The objective of this study was to determine the efficacy of Aloe vera gel at 80% compared to 0.12% Chlorhexidine gel to alleviate the effects derived from any orthodontic treatment, such as gingival inflammation and hyperplasia and friction or ulcerations. of traumatic oral mucosa-derived from treatment in patients after cementation with metal brackets in the two arches. A total of 140 patients between the ages of 10 and 55 who were randomized and assigned in the two study groups treated with Aloe vera gel versus the conventional Chlorhexidine gel with a sample of 70 subjects in each group participated. The index of gingival inflammation, plaque index, as well as the simplified hemorrhage index, were evaluated.

NCT ID: NCT03632902 Completed - Airway Management Clinical Trials

Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysms

Start date: June 26, 2018
Phase:
Study type: Observational

Endovascular techniques for the treatment of intracranial aneurysms are growing.

NCT ID: NCT03631784 Completed - Clinical trials for Non-small Cell Lung Cancer

A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)

KEYNOTE-799
Start date: October 19, 2018
Phase: Phase 2
Study type: Interventional

This is a trial in adult participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC) treated with pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy followed by pembrolizumab monotherapy. The primary hypothesis of the trial is that within each platinum doublet chemotherapy cohort, the percentage of participants who develop Grade 3 or higher pneumonitis is ≤10% and objective response rate (ORR) by blinded independent central review (BICR).

NCT ID: NCT03630887 Completed - Clinical trials for Perioperative/Postoperative Complications

Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection

Start date: August 14, 2018
Phase: N/A
Study type: Interventional

Hypothermia is a frequent perioperative complication. When the negative effects of anesthesia on temperature are aggravated by other factors, such as glycine infusion in transurethral resection, temperature can decrease even more. Preoperative warming prevents hypothermia, lowering the temperature gradient between core and peripheral compartments and reducing thermal redistribution. The most recent clinical practice guidelines advocate for active prewarming before induction of general anaesthesia since it is very effective in preventing perioperative hypothermia. However, the ideal warming time prior to the induction of anesthesia has long been investigated. This study aims to evaluate the optimal time period of preoperative forced-air warming to reduce the incidence of hypothermia at the end of surgery in patients submitted to transurethral resection. This is a clinical trial comparing different time periods of prewarming in patients submitted to undergo elective transurethral resection. We will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. 144 patients are going to be included in this study (36 patients in each group). Measurement of temperature will be performed using a tympanic thermometer. Patients will be followed throughout their hospital admission. Data will be recorded using a validated instrument and will be analysed using the statistics program R Core Team.

NCT ID: NCT03630588 Completed - Obesity, Abdominal Clinical Trials

Effect of the Consumption of an Enriched Surimi in Abdominal Visceral Adiposity

Start date: August 2, 2018
Phase: Phase 2
Study type: Interventional

The finding that the combination of the inactivated probiotic Bifidobacterium Lactis (BPL1), inulin as a source of soluble fiber and omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in a surimi matrix has positive effects on visceral adiposity , insulin resistance and plasma tryclycerides in a preclinical model of rats that present obesity induced by diet is the basis of the present hypothesis. This finding is based on the fact that these three bioactive compounds exert these effects through sensibly different and complementary mechanisms, which suggests that their combined use may have synergistic effects. On this basis the present hypothesis is posed: the consumption of surimi enriched with inactivated probiotic BPL1, inulin and omega-3 fatty acids, in the same doses that have been effective in obese rats (SIAP), can induce a reduction of more than 5% of visceral adipose tissue, being clinically relevant in people with abdominal obesity. If the effect on abdominal obesity is associated or not with a lower glycemia and / or absorption of fats induced by the consumption of surimi can be evaluated by monitoring these parameters for 4 hours after the ingestion of a breakfast high in fat. The main objective of this study was to evaluate the effects of the consumption of surimi enriched with the probiotic BPL1, inulin and omega-3 fatty acids, on visceral abdominal adiposity in people with abdominal obesity.

NCT ID: NCT03629782 Completed - Severe Asthma Clinical Trials

Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy

RECOGNISE
Start date: April 26, 2018
Phase:
Study type: Observational

This is a multi-country, multicentre, observational cross-sectional one-visit study of patients suffering from severe asthma in primary and secondary care settings in Europe