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NCT ID: NCT03895203 Completed - Psoriatic Arthritis Clinical Trials

A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

BE OPTIMAL
Start date: April 3, 2019
Phase: Phase 3
Study type: Interventional

This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).

NCT ID: NCT03894969 Completed - Clinical trials for Respiratory Disorders

Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine

Start date: April 23, 2019
Phase: Phase 2
Study type: Interventional

This study will provide information regarding the sequential administration of two vaccines adjuvanted with AS01. The aim of this study is to understand immunogenicity and safety of NTHi-Mcat vaccine when administered sequentially after Shingrix vaccine and to compare to the immunogenicity of NTHi-Mcat vaccine administered alone. This study will also provide information regarding whether a specific time period is required between the administration of these two different vaccines containing the same adjuvant- AS01 components. The population of this study will include healthy smokers and ex-smokers of 50 to 80 years of age which will be used as a proxy for the COPD population.

NCT ID: NCT03894618 Completed - Melanoma Clinical Trials

SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas

Start date: March 26, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas.

NCT ID: NCT03894514 Completed - Knee Osteoarthritis Clinical Trials

Multi-variable Prediction Model of Total Knee Replacement Outcome

Start date: May 1, 2019
Phase:
Study type: Observational

Total knee arthroplasty (TKA) is a surgical procedure applied as a common solution to overcome limitations produced by advanced stages of severe gonarthrosis. The procedure has high prevalence, high associated costs, and is considered to be cost-effective. Rehabilitation is essential to optimize outcomes. However, in clinical practice, the length of rehabilitation for each patient may be highly variable, and the programmed times may lack the necessary objectivity. Current limitation of resources and increasing prevalence make essential to generate strategies to optimize surgical results, so that the use of resources of the health system is efficient without detriment to the patient's benefit. For this purpose, objective and pragmatic information must be available, and should be based on scientific evidence in order to assist in making clinical decisions. Indeed, a number of demographic, biomedical and psychosocial factors have been identified as predictors of TKA results (i.e weight, age, expectations...). Some of them have been associated with the need for hospital resources after surgery. However, most researches base their predictions in retrospective studies, which are limited in the type of variables that can be used (clinic history), quality of registries, and limitations of retrospective designs. On the other hand, most of prospective researches base their predictions in a limited number of outcomes. To overcome this limitations, this project has been designed as a prospective observational study with two observations of each patient. - The primary goal is to implement a multi-variable prediction model of TKA outcome, so that the procedure become optimal in two aspects : patient recovery (social and economic benefit) and use of health system resources (economic benefit). The implementation requires a processing of the information sampled through various algorithms and innovative data processing in this field, based on data mining and machine learning techniques. This will be used in search of the model with the greatest predictive capacity. - As a secondary objective, information extracted from patients both in the final stages of the condition, and in the medium term after the intervention will allow to study the functional and psychosocial reality of the subjects with knee osteoarthritis.

NCT ID: NCT03893864 Completed - Aging Clinical Trials

Bioavailability and Impact of Coenzyme Q10 in Stressing Exercise in Senescence Athletes

CoQ10Sport
Start date: March 1, 2018
Phase: Phase 1
Study type: Interventional

It is proposed to establish a group of subjects composed of 10 healthy individuals of> 50 years and <65, physically active, without metabolic or inflammatory pathology. All of them will undergo a health examination and the physical condition and the absence of contraindication of the sports practice will be characterized through a monitored effort test. Each subject will take a capsule of coenzyme Q10® INDENA for 30 days. The dose to be administered is 100 mg/d of CoQ10 a with food (noon). The state of physical condition and the biochemical and biological variables that reflect oxidative stress and mitochondrial functioning before and after the intervention will be measured.

NCT ID: NCT03891524 Completed - Clinical trials for Arthroplasty, Replacement, Knee

A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery

AXIOMATIC-TKR
Start date: June 17, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy of JNJ-70033093 in preventing total venous thromboembolism (VTE) events (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death) during the treatment period.

NCT ID: NCT03890965 Completed - Clinical trials for Neurological Disorder

Effects of the Application of a Reflex Locomotion Program in the Neurological Hand

Start date: May 29, 2019
Phase: N/A
Study type: Interventional

The recovery of the function of the hand is one of the most important aspects for patients who have suffered the consequences of neurological damage. Currently there are numerous therapeutic procedures aimed at rehabilitation that have scientific evidence such as restrictive therapy. However, dysfunction of the upper limb has an impact on the whole body that is not always taken into consideration.

NCT ID: NCT03890744 Completed - Clinical trials for Metastatic Breast Cancer

ModraDoc006/r in Patients With Breast Cancer

Start date: January 30, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter phase IIa study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with recurrent or metastatic HER-2 negative breast cancer, that are suitable for treatment with a taxane as 1st-3rd line of therapy.

NCT ID: NCT03890445 Completed - Crohn´s Disease Clinical Trials

Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease

GIANT
Start date: June 24, 2019
Phase:
Study type: Observational

Hyrimoz™ was developed as a biosimilar to HumiraTM (INN: adalimumab) and Zessly™ was developed as a biosimilar to RemicadeTM (INN: infliximab). Within the Biosimilar Development Program of Hyrimoz™ and Zessly™, two clinical confirmatory efficacy and safety studies were conducted: Hyrimoz™ in plaque psoriasis and Zessly™ in rheumatoid arthritis. Both confirmatory Phase III studies demonstrated equivalent efficacy and similar safety and immunogenicity of Hyrimoz™ to HumiraTM and Zessly™ to RemicadeTM, respectively. The current study is designed to provide a systematic and consistent overview of the real-world data in biologic-naïve patients with moderate-to-severe Crohn's disease (CD). The data collected in this observational trial will be used to increase the knowledge of the effectiveness of Hyrimoz™ and Zessly™ in clinical routine care in patients with moderate-to-severe CD.

NCT ID: NCT03889665 Completed - Healthy Clinical Trials

Effects of Suspension Training on the Balance of Healthy Young Adults

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

Non-specific training through the use of devices in which the subject can be suspended is a technique that has aroused a growing interest in recent years. One of its advantages may be to enhance the balance, since it induces a high level of neuromuscular stimulation. Indeed, a suspension training suppose a high demand of the core musculature, require a high degree of postural control, precise response strategies , anticipatory capacity and muscular conditioning. However, current literature targeting healthy young adults and appraising the specifics effects of suspension training on balance is scarce or non-existent to the best of our knowledge. For this reason this interventional study will primarily assess the effects of suspension training on different balance components.