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NCT ID: NCT03785925 Completed - Neoplasm Metastasis Clinical Trials

A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer

PIVOT-10
Start date: April 29, 2019
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.

NCT ID: NCT03785535 Completed - Fibromyalgia Clinical Trials

Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia

Start date: January 15, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of low-intensity and prolonged vibrotactile sensory stimulation on brain activity and functional connectivity in fibromyalgia patients.

NCT ID: NCT03785405 Completed - Heart Failure Clinical Trials

CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

Start date: May 2, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.

NCT ID: NCT03784196 Completed - Healthy Clinical Trials

Changes of Pain Sensitivity During Rehabilitation of Patients Suffering From Whiplash Associated Disorders

Start date: May 16, 2016
Phase:
Study type: Observational [Patient Registry]

This study investigates the sensory profile of people suffering from whiplash associated disorders (WAD) during rehabilitation.

NCT ID: NCT03784079 Completed - HIV Infections Clinical Trials

A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults

Start date: January 31, 2019
Phase: Phase 2
Study type: Interventional

Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities. Hence, there is a need to prevent these co-morbidities. GSK3640254 is a next-generation HIV-1 Maturation Inhibitor (MI) which may be effective for HIV-1 infection. This study will evaluate the antiviral effect, safety, tolerability and pharmacokinetics/ pharmacodynamics of GSK3640254 in HIV-1 infected treatment-naive adults. This study will consists of two parts; Part 1 and Part 2. Part 1 will evaluate two active doses of GSK3640254, 200 milligrams (mg) (Cohort 1) and 10 mg (Cohort 2) along with placebo to match GSK3640254 Mesylate salt. Part 2 will evaluate three active doses of GSK3640254. Dose level 1 of GSK3640254 that can provide at least 30 percent of the maximum effect (Cohort 1), dose level 2 of GSK3640254 that can provide at least 75 percent of the maximum effect (Cohort 2) and dose level 3 of GSK3640254 that can provide at least 90 percent of the maximum effect (Cohort 3). These doses are anticipated to be 5 mg, 40 mg and 100 mg respectively, but could be modified based on data obtained in Part 1. Subjects will also receive placebo to match GSK3640254 Mesylate salt in Part 2 of the study. All doses will be administered after a moderate fat meal. This study will consist of Screening period (up to 14 days), Treatment period (Day 1- Day 10), post-dose Follow-up (Day 11- Day 17) and final Follow-up (Day 18-24). A total of approximately 34 subjects will be enrolled, of which, 14 subjects will be randomized in Part 1 and 20 in Part 2 of the study. Six subjects will be enrolled in each of the active dose cohorts and 2 subjects will be enrolled in each of the placebo cohorts.

NCT ID: NCT03783221 Completed - Healthy Clinical Trials

Effect of Previous Diet

Start date: October 22, 2018
Phase: N/A
Study type: Interventional

Meal ingestion induces digestive responses associated to homeostatic and hedonic sensations. The responses to meal ingestion are modulated by conditioning factors. Single-centre, cross-over, random, open label study comparing the effect of a high-fat/low-residue diet versus low-fat/high residue diet on the responses to meal ingestion. In 20 healthy subjects each diet will be administered during 2 weeks in random order; each diet will be preceded by 2 weeks washout, balanced diet. The aim of the study is to compare the effects of each diet on the responses to comfort and flatulogenic meals, intestinal gas production and digestive sensations.

NCT ID: NCT03783156 Completed - Clinical trials for Gastrointestinal Bleeding

Polypectomy With Hot vs Cold Snare in Small Colonic Lesions

Polypech-c
Start date: February 18, 2019
Phase: N/A
Study type: Interventional

Colonoscopy is the technique of choice for the diagnosis and prevention of colorectal cancer (CRC). The identification and extirpation of adenomas decreases the incidence of CRC by up to 76%. More than 70% of the excised lesions are less than 10 mm. There is controversy about the technique to be used (resection with cold vs hot snare) in lesions of 5-9mm. Both use a polypectomy snare. The cold snare cuts by friction, while the hot snare uses electrical current. We propose a multicenter randomized clinical trial comparing both endoscopic techniques. At least 394 injuries per group will be included, randomizing patients to whom a diagnostic colonoscopy is requested for symptoms, screening or revision protocols. Randomization will be performed stratified by center. The primary objective is the proportion of incomplete polypectomies, which will be analyzed centrally from random biopsies of the edges of the lesion. As secondary objectives, we will compare the proportion of immediate and delayed hemorrhagic complications, the evolution of postprocedural abdominal pain and the factors associated with incomplete excision in each group and the factors associated with a failed cold polypectomy. The analysis of the primary objective will be carried out by means of the z test of homogeneity without using the correction of Yates, estimating the confidence interval of the difference between both groups. The analysis will be carried out by intention to treat and per protocol.

NCT ID: NCT03783078 Completed - Clinical trials for Merkel Cell Carcinoma

Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)

Start date: February 25, 2019
Phase: Phase 3
Study type: Interventional

This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.

NCT ID: NCT03783026 Completed - Psoriatic Arthritis Clinical Trials

A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis

MOSAIC
Start date: February 6, 2019
Phase: Phase 4
Study type: Interventional

This study is designed to assess the efficacy of apremilast, either in monotherapy or with stable methotrexate, on imaging outcomes in adults with active psoriatic arthritis with less than 5 years of disease duration (since diagnosis), and who are naïve to biologic therapies.

NCT ID: NCT03782779 Completed - Aging Clinical Trials

Diaphragmatic Breathing Program In Older People

BP-OP
Start date: January 3, 2019
Phase: N/A
Study type: Interventional

In the present study a program of respiratory physical therapy based on diaphragmatic breathing is applied in institutionalized old people, evaluating lung function parameters (FVC, FEV1, FEV1/FVC) and oxygen saturation. The hypothesis is that a diaphragmatic breathing program applied in elderly people can improve the respiratory system's function and consequently improve their daily life. This program will include learning and performing a diaphragmatic-abdominal breathing, and incorporating the new breathing pattern to a upper and lower limbs maintenance exercises as well as to daily life activities. Methods: randomized and controlled clinical study of respiratory parameters of institutionalized old people. The subjects will be divided into 2 groups: 1) diaphragmatic breathing program and upper and lower limbs maintenance exercises 2) control group which do upper and lower limbs maintenance exercises. There will be 3 treatment sessions during 8 weeks, with evaluations before the study and after 8 weeks, which include: lung function parameters (forced vital capacity, forced expiratory volume in one second, Tiffeneau Index) and pulseoximeter (which includes oxygen saturation and cardiac frequency).