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NCT ID: NCT03519256 Terminated - Clinical trials for Urinary Bladder Neoplasms

A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder

CheckMate 9UT
Start date: August 2, 2018
Phase: Phase 2
Study type: Interventional

A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.

NCT ID: NCT03513809 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Inflammation and Distribution of Pulmonary Ventilation Before and After Tracheal Intubation in ARDS Patients

Start date: June 8, 2017
Phase:
Study type: Observational [Patient Registry]

Spontaneous breathing efforts in patients with respiratory failure connected to mechanical ventilation, has been associated with strong respiratory muscles activity. However, these mechanisms may will be present in patients with acute lung deseases who are breathing with no ventilatory support. We hypothesize that spontaneous breathing during acute respiratory failure could induced lung inflammation and worsen lung damage. Hereby, the connection to a ventilatory support tool, may protect the lungs from spontaneous ventilation-induced lung injury. To test our hypothesis, our aim is to determine the effects of spontaneous breathing in acute respiratory failure patients, on lung injury distribution; and to determine whether early controlled mechanical ventilation can avoid these deleterious effects by improving air distribution.

NCT ID: NCT03508674 Completed - Clinical trials for Bariatric Surgery Candidate

Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System

Start date: April 20, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures

NCT ID: NCT03505723 Completed - Venous Thrombosis Clinical Trials

PeriOperative ISchemic Evaluation-3 Trial

POISE-3
Start date: June 27, 2018
Phase: Phase 3
Study type: Interventional

This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.

NCT ID: NCT03504397 Active, not recruiting - Clinical trials for Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer

Spotlight
Start date: June 21, 2018
Phase: Phase 3
Study type: Interventional

A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric or GEJ cancer - metastatic gastric or GEJ cancer. These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells. For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death. Patients will be assigned to one of two groups by chance and given either: - zolbetuximab with mFOLFOX6; or - a placebo with mFOLFOX6. A placebo is a treatment that looks like the experimental medicine, but contains no medicine. The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.

NCT ID: NCT03502304 Completed - Clinical trials for Metabolic Disturbance

Concurrent Training and Prediabetes Control

Start date: June 10, 2017
Phase: N/A
Study type: Interventional

Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes).

NCT ID: NCT03502109 Completed - Hypertension Clinical Trials

Pharmacist-led Medication Review With Follow-up on Primary Care Cardiovascular Older Adult Patients.

POLARIS
Start date: January 5, 2018
Phase: N/A
Study type: Interventional

Hypothesis: Medication Review with follow-up can improve clinical, health related quality of life and economic outcomes. To prove this hypothesis a cluster randomized controlled trial will be held in primary care centres of the public health system of Chile. Patients of the cardiovascular disease prevention program, older than 65 years and with poly pharmacy (more than 5 drugs) will be recruited. Control group will receive usual care and the intervention arm will have medication review consultations by a pharmacist every 4 months for one year. Clinical interventions will be made with physician authorisation. Participating pharmacist will be trained in cardiovascular prevention pharmacotherapy in the elderly, interview skills and educational techniques. A practice change facilitator will assist the pharmacist in any matters regarding the methodology and will asses barriers and facilitators to the implementation of the medication review with follow-up service. A personalised plan will be developed for every pharmacist. Clinical outcomes (blood pressure, HbA1c, LDL cholesterol, overall cardiovascular risk, among others), number of medications, adherence rate and health-related quality of life will be evaluated. A cost-utility analysis will be made through the health ministry of Chile perspective.

NCT ID: NCT03498521 Active, not 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 poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy.

NCT ID: NCT03496298 Terminated - 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 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk. Secondary Objectives: To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants 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 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.

NCT ID: NCT03486873 Recruiting - Solid Tumors Clinical Trials

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

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

The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.