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NCT ID: NCT03599245 Recruiting - Multiple Sclerosis Clinical Trials

This is an Extension Study of the Roche P-trial to Investigate Safety and Effectiveness of a Single Ocrelizumab Dose in Participants With Multiple Sclerosis (MS)

Start date: July 12, 2018
Phase: Phase 3
Study type: Interventional

This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).

NCT ID: NCT03569293 Recruiting - Atopic Dermatitis Clinical Trials

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1

Start date: August 13, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe Atopic Dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT03563183 Recruiting - Herpes Zoster Clinical Trials

A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022

Start date: January 10, 2010
Phase:
Study type: Observational

As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study. The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.

NCT ID: NCT03517787 Recruiting - Clinical trials for Spinal Cord Injuries

The Effect of FES and Therapeutic Exercise on SCI Patients Skeletal Muscles, Sitting Balance, Posture and Quality of Life

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Aim of the current study is to evaluate the effect functional electrical stimulation and therapeutic exercise on traumatic spinal cord injured participants`skeletal muscle characteristics, sitting balance, lung function and quality of life.

NCT ID: NCT03502525 Recruiting - Clinical trials for Substance Abuse, Intravenous

Break the Cycle: Prevention for Reducing Initiation Into Injection Drug Use

Start date: August 31, 2016
Phase: N/A
Study type: Interventional

Break the Cycle is a two-session, one-on-one, in-person intervention study designed to reduce the role persons who inject drugs (PWID) play initiating non-PWID into injection drug use. Study implementation is at two sites: New York City and Tallinn, Estonia. At baseline, quantitative data are collected via a structured computer-assisted personal interview, after which the intervention is conducted. At the 6-month follow-up, a modified version of the interview is repeated. The study uses a pre- versus post- design to compare the proportion of participants who helped with first injections, and who promoted injecting among non-PWID, in the 6 months prior to baseline with the proportions at the 6-month follow-up. Based on previous research on the intervention and on the underlying theory of motivational interviewing, increases in helping and promoting behaviors between baseline and follow-up would indicate that the intervention was not effective regardless of their effect size. Accordingly, the hypotheses that the intervention will produce reductions in assisting with first injections and engaging in injection promoting behaviors will be evaluated using one-tailed statistical tests. Break the Cycle intervention follows a motivational interviewing approach to enhance current injectors' motivation and skills to avoid helping with and promoting first injections among non-PWID. The intervention's core is a discussion between an interventionist and each participant on the following eight topics: the participant's first time injecting drugs; the participant's exposures to situations where helping with others' first injections is an option, and the extent to which they have helped; PWIDs' behaviors that might encourage non-PWID to inject for the first time; the range of risks associated with injection drug use; role-playing scenarios in which the participant develops behaviors and scripts for avoiding or refusing requests to initiate others into injection drug use; role- playing talking with other PWID about not encouraging non-PWID to start injecting; imparting safer injection practices when helping with a first injection seems like the best option; and receiving training in and using Narcan to reverse overdoses.

NCT ID: NCT03498521 Recruiting - Clinical trials for Cancer of Unknown Primary Site

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

CUPISCO
Start date: July 10, 2018
Phase: Phase 2
Study type: Interventional

This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum doublet induction chemotherapy.

NCT ID: NCT03496298 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Effect of Efpeglenatide on Cardiovascular Outcomes

AMPLITUDE-O
Start date: April 27, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: -To demonstrate that, efpeglenatide doses 1 and 2 is noninferior to placebo on 3-point major adverse cardiac event (MACE) in Type 2 diabetes mellitus (T2DM) patients at high cardiovascular (CV) risk. Secondary Objectives: - To demonstrate that efpeglenatide doses 1 and 2 is superior to placebo in T2DM patients with high CV risk on the following parameters: - 3-point MACE. - Expanded CV outcome. - Composite outcome of new or worsening nephropathy. - To assess the safety and tolerability of efpeglenatide doses 1 and 2, both added to standard of care in T2DM patients at high CV risk.

NCT ID: NCT03467581 Recruiting - Metabolic Surgery Clinical Trials

Five-year Outcome of Laparoscopic Gastric Sleeve

Start date: October 8, 2008
Phase: N/A
Study type: Observational

The aim of this study is to evaluate the long-term (5-year follow-up) results of laparoscopic gastric sleeve (LGS) in terms of weight loss and obesity related comorbidities, as well as the risk factors associated with postoperative nutritional deficiencies.

NCT ID: NCT03439657 Recruiting - Herpes Zoster Clinical Trials

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older

Start date: April 12, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.

NCT ID: NCT03433482 Recruiting - Clinical trials for Meningitis, Meningococcal

A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age

Start date: August 30, 2018
Phase: Phase 2
Study type: Interventional

MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries. The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by storage at 2-8ºC.