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NCT ID: NCT03228485 Active, not recruiting - Clinical trials for Lower Urinary Tract Symptoms

Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study

Start date: April 4, 2019
Phase:
Study type: Observational

This study assesses the feasibility, and acceptability of a (mobile) application for men presenting at their physician's office with LUTS/BPH; starting with medical therapy and naïve for treatment. Patients will be enrolled in the study by their physician (GP or urologist). The patients will receive a daily medication reminder including frequent feedback on medication adherence. Furthermore, standard questionnaires will be filled out via the application. The hypothesis of this pilot study is that application is feasible and accepted in this group of patients.

NCT ID: NCT03225612 Recruiting - Heart Valve Disease Clinical Trials

Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

SCOUT-II
Start date: May 22, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation. The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.

NCT ID: NCT03224338 Completed - HIV II Infection Clinical Trials

Dolutegravir Plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects

Start date: April 5, 2017
Phase: Phase 2
Study type: Interventional

Multicenter, single-arm, open-label clinical trial to evaluate the efficacy, the safety and the tolerability of 50 mg dolutegravir once daily (q.d.) given in combination with 2 NRTIs backbone in HIV-2 positive, treatment-naïve subjects.

NCT ID: NCT03223012 Completed - Psoriasis Clinical Trials

Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service

IMPROVE
Start date: November 15, 2017
Phase:
Study type: Observational

This study aims to evaluate the impact of AbbVie Care 2.0 on adalimumab's compliance, patient reported outcomes and utilization of health resources over 12 months.

NCT ID: NCT03217006 Active, not recruiting - Clinical trials for Coronary Artery Disease

Randomization of Single vs Multiple Arterial Grafts

ROMA
Start date: January 7, 2018
Phase: N/A
Study type: Interventional

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

NCT ID: NCT03209141 Completed - Hypertension Clinical Trials

Screening of Diastolic Dysfunction With Impedance Cardiography in Hypertensive Patients

IMPEDDANS
Start date: January 2, 2015
Phase:
Study type: Observational

Arterial hypertension (AHT) is responsible for important morbidity and mortality. The cardiac repercussion of AHT is usually assessed by electrocardiography and echocardiography, time-consuming, technically demanding examinations that require experienced operators, which limits their use for screening diastolic dysfunction. Alternative tools for the screening of diastolic function in hypertensive patients are needed. Impedance cardiography (IC) is presently used in the study of AHT and in the optimization of antihypertensive therapy. It seems an attractive and economical option to change the clinical approach for screening; however, its validation in well-defined populations is required to sustain its use in clinical practice. The IMPEDDANS study aims to validate IC for screening left ventricular diastolic dysfunction in outclinic patients with AHT, using functional echocardiography as the clinical standard. Descriptive and analytical study with analysis of the agreement between the diagnosis of diastolic dysfunction and its degree, as well as the parameters obtained by impedance cardiography and echocardiography in patients with AHT.

NCT ID: NCT03204318 Completed - Clinical trials for Endometriosis Related Pain

SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

Start date: December 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.

NCT ID: NCT03202498 Terminated - Liver Cirrhosis Clinical Trials

Safety and Tolerability of Yaq-001 in Patients With Cirrhosis

Start date: February 28, 2019
Phase: N/A
Study type: Interventional

In patients with cirrhosis (scarring of the liver), bacterial fragments leak from the gut into the blood and cause harm. This study looks into a new way to lower the leakage of bacterial fragments into the blood. Yaq-001 is a new type of carbon that in previous laboratory studies has been shown to have the ability to bind these bacterial fragments and so confine them to the gut. The purpose of this clinical trial is to test the product Yaq-001 for the first time in patients with cirrhosis. This trial will assess if the treatment with Yaq-001 is safe, is well tolerated, and if it helps improve the overall health status of the cirrhotic patients. Candidate patients must be at least 18 years old and have a clinical diagnosis of cirrhosis for any cause. Only postmenopausal women or with surgical sterilisation are eligible. Additional inclusion and exclusion criteria of medical nature will be determined with the investigator at the screening visit, by means of standard care routines plus an additional test to assess the bowel transit time. Eligible patients will be randomly grouped to receive standard care treatment plus Yaq-001, or standard treatment plus placebo (non-active treatment). The use of placebo is necessary to better understand how safe and tolerable Yaq-001 really is. The treatment lasts for 12 weeks. During treatment, the patient will be visited by a study doctor 5 times. At all the visits the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital. 56 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

NCT ID: NCT03200665 Completed - Clinical trials for Condition of Fetal Growth or Malnutrition (Diagnosis)

Sonographic Evaluation of Fetal Growth in the Third Trimester of Low-risk Pregnancy: a Randomized Trial

Start date: July 2015
Phase: N/A
Study type: Interventional

Sonographic fetal weight estimation at the last weeks of third trimester in low-risk pregnancies is an effective method for diagnosis of fetal growth restriction (FGR) permitting close surveillance and timely delivery. The need for a systematic ultrasound evaluation at the last weeks of a low-risk pregnancy and the best time to perform it remains controversial. The most commonly used clinical screening tool in this population is the serial measurement of symphysis-fundus distance, which is a method of a variable and low sensitivity for detection of FGR. In Portugal, in accordance with guidelines of Direcção Geral de Saúde from 2015, fetal growth restriction screening in low risk pregnancies is performed with an ultrasound for fetal weight estimation at 30th-33rd weeks. Nonetheless, recent data from randomized trials showed that FGR detection rate was superior at 36 vs 32 weeks' gestation. In cases of severe FGR, detection rate was also superior at 36 vs 32 weeks' gestation. In a prior retrospective study, our group analyzed 1429 term low risk pregnancies and the investigators concluded that small for gestational age term babies (birthweight < 10th centile) had a statistically significant higher rate of operative deliveries for intrapartum fetal distress than appropriate for gestational age as well as a higher rate of admission to neonatal intensive care unit. Moreover the investigators compared the same outcomes within small for gestational age neonates with antepartum detection at 30th-33rd weeks ultrasound vs undetected (normal 30th-33rd weeks ultrasound). Antepartum detection of small for gestational age neonates showed a statistically significant lower rate of operative deliveries for intrapartum fetal distress than undetected small for gestational age neonates. The investigators will conduct a prospective randomized clinical trial with the aim to evaluate if a 35th-37th weeks after the standard of care ultrasound in low risk pregnancies is effective in improving the detection rate of FGR and in reducing cesarean deliveries for intrapartum fetal distress and admission to neonatal intensive care unit.

NCT ID: NCT03194581 Terminated - Hemorrhage Clinical Trials

Normoxic Challenges Utility to Evaluate Blood Loss

Start date: October 1, 2017
Phase:
Study type: Observational

This study will evaluate the impact of repeated normoxic challenges on cerebral oxygenation as a measure of the effect of blood loss on DO2 during surgical procedures.