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NCT ID: NCT02859935 Completed - Risk Behavior Clinical Trials

A SYNdemic BASed INtervention for MSM With High Risk Behavior: Design of a Randomized Controlled Trial

SYNBASIN
Start date: September 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled intervention study at the STI outpatient clinic of Amsterdam is to answer the following questions : Does a personalised behaviour intervention comprising of targeted in-depth screening on mental health problems and drug use and, in case identified, subsequent linkage to care increase help seeking behaviour, and decrease risk behaviour in MSM who are at high risk for STIs and HIV?

NCT ID: NCT02859727 Active, not recruiting - Clinical trials for Activated PI3Kdelta Syndrome (APDS); PASLI Disease

Extension to the Study of Efficacy of CDZ173 in Patients With APDS/PASLI

Start date: September 8, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study is designed to provide long-term CDZ173 treatment, a selective PI3Kδ inhibitor, to the patients with genetically activated PI3Kδ, i.e., patients with APDS/PASLI who participated in the CCDZ173X2201 study or who were treated previously with PI3Kδ inhibitors other than CDZ173. The study is open-label designed to establish the long-term safety, tolerability, efficay and pharmacokinetics of CDZ173 in the target population.

NCT ID: NCT02858453 Active, not recruiting - Clinical trials for Interstitial Cystitis

Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome

LEADERSHIP 301
Start date: July 2016
Phase: Phase 3
Study type: Interventional

This study evaluates the effects of two doses of oral AQX-1125 on bladder pain and other urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome. Participants will receive either 100 mg AQX-1125, 200 mg AQX-1125 or placebo for the first 12 weeks of the study. After 12 weeks, all participants will receive either 100 mg or 200 mg AQX-1125 for 52 weeks.

NCT ID: NCT02857829 Completed - Clinical trials for Biomedical Enhancement

The Effects of a Combination of Nootropic Ingredients on Cognition in Healthy Young Volunteers

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

Achieving optimal concentration during cognitively demanding tasks is of immense human value. Despite our understanding of the important role that attention, working memory, and fluid intelligence play in professional success, and the huge individual differences in these constructs, the modulation of these cognitive domains has not been rigorously studied. From the widespread use of caffeine, to the more questionable and increasing use of prescription medications to achieve peak attention, the tremendous interest in achieving cognitive performance has driven individuals to experiment, often with prescription and illegal drugs. Herein, we aim to standardize and extend the study of attention modulating substances, to identify blends that achieve safe enhancements in attention and working memory. Specific to this proposal, we aim to develop CAF+, a blend of natural and generally regarded as safe compounds to improve attention and working memory in normal, healthy individuals. CAF+ is composed of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg), pyridoxine (0.06 mg), and cobalamin (20 mg).

NCT ID: NCT02857439 Recruiting - Trauma Clinical Trials

Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial

CASH
Start date: July 2016
Phase: N/A
Study type: Interventional

What combination of ≤ 6 clinical variables will give the highest specificity for indicating significant shoulder injuries (fractures or dislocations) with a set sensitivity of ≥ 97%? Although shoulder trauma is a common injury, there is no clinical decision rule to determine the necessity for radiography for these traumas. With this trial the investigators aim to develop such a rule to reduce the amount of radiographs without missing any significant injuries. The primary objective is to compose a set of clinical diagnostic criteria predictive of shoulder fractures or dislocations that would reduce the amount of radiographs without missing any significant injuries. A second objective is to determine if the clinical decision rule is applicable for triage use.

NCT ID: NCT02856373 Terminated - Clinical trials for Arrhythmias, Cardiac

Renal Nerve Stimulation and Renal Denervation in Patients With Sympathetic Ventricular Arrhythmias

Redress VT
Start date: March 3, 2015
Phase: Phase 2
Study type: Interventional

Rationale: Sympathetic activity plays an important role in the pathogenesis of ventricular tachyarrhythmia. Previous studies have shown evidence of significant heritable influences on individual responses to adrenergic stimulation. Catheter-based renal sympathetic denervation (RDN) is a novel treatment option for patients with resistant hypertension, proved to reduce local and whole-body sympathetic activity. The investigators hypothesize that percutaneous transluminal electrical stimulation of the sympathetic nerve bundles in the renal arteries will cause ventricular arrhythmias and renal denervation will suppress these arrhythmias in patients with sympathetic ventricular arrhythmias. Objective: This study will investigate the effects of renal nerve stimulation before and after percutaneous transluminal RDN on cardiac excitable properties including induction of ventricular tachy-arrhythmias before and after RDN in six studies, i.e. patients with catecholaminergic polymorphic ventricular tachycardia (CPVT), long QT syndrome and arrhythmogenic right ventricular cardiomyopathy (ARVC), sympathetically driven ventricular arrhythmias, hypertrophic cardiomyopathy (HCM), dilated non-ischemic cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM). The aim of the six studies is to assess the anti-arrhythmic effects of RDN in patients with sympathetic ventricular tachy-arrhythmias. Study design: Investigator initiated, multi centre, six pretest-posttest design studies. Study population: Patients with recurrent sympathetically driven ventricular arrhythmia despite optimal pharmacological therapy. Patients should be diagnosed with CPVT and certain types of long QT syndrome, ARVC, HCM, DCM and ICM. Eligible patients will be in the age category of 18-85 year. Intervention: RDN will be performed according to routine clinical practice. Prior to the ablation procedure, catheter mapping of the renal arteries will be performed according to routine clinical practice. Clinical and biological responses to transluminal electrical renal nerve stimulation will be assessed before and after RDN. Study endpoints: - Main procedural study endpoint: Induction of ventricular arrhythmias in response to renal nerve stimulation prior to RDN and absence of renal nerves stimulation induced ventricular arrhythmias after RDN. - Main clinical study endpoint: Development of ventricular arrhythmia during exercise stress testing performed 6 months after procedure. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In several studies, it was shown that RDN was safe. The intervention resulted in significantly better control of blood pressure with less medication, and beneficial changes in heart rate variability, autonomic sympathetic balance, renal arteriolar function, and a higher success of atrial fibrillation prevention. In case reports and case series, RDN had a favourable effect in patients with sympathetic drug refractory ventricular tachy-arrhythmias.

NCT ID: NCT02855164 Terminated - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)

FLIGHT-FXR
Start date: August 1, 2016
Phase: Phase 2
Study type: Interventional

The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

NCT ID: NCT02854436 Completed - Prostatic Neoplasms Clinical Trials

An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Galahad
Start date: August 31, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.

NCT ID: NCT02853162 Terminated - Clinical trials for Renal Cell Carcinoma

Ablative tReatment of Inoperable REnal Cell Carcinoma Using STereotactic Body Radiotherapy (ARREST-study)

ARREST
Start date: June 2016
Phase: Phase 2
Study type: Interventional

Phase II study (n=30) to evaluate the safety and feasibility of stereotactic body radiation therapy (SBRT) with fiducial markers in inoperable patients with renal cell carcinoma (RCC).

NCT ID: NCT02853123 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients

Start date: September 22, 2016
Phase: Phase 4
Study type: Interventional

The primary objective of the present study is to evaluate the effect of tiotropium + olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity of breathlessness during the 3min constant speed shuttle test (CSST). A secondary objective is to explore the relationship between reductions in breathlessness during the 3min CSST and reductions in breathlessness during activities of everyday living as measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following bronchodilator therapy.