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NCT ID: NCT02761083 Withdrawn - Ptosis Clinical Trials

PMCF-study Using Novosyn® Quick Suture Material in Ophthalmic Surgery

OPHTHALNOQ
Start date: May 2016
Phase: Phase 4
Study type: Interventional

The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with standard suture material used in Ophthalmic surgery. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be compared in 2 treatment groups. Active control group will receive Vicryl® Rapide and the treatment group Novosyn® Quick for ophthalmic surgery. It was decided to design this study as a randomized trial, because limited clinical evidence is available in the literature for the active control group (Vicryl® Rapide) which can be used for comparison. Eye operation will be randomly allocated on the left and right side (1:1) to both treatment groups. Patients undergoing elective, primary ophthalmic surgery (dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, blepharoplasty)

NCT ID: NCT02757287 Withdrawn - Infertility Clinical Trials

Desogestrel (DSG) and Corifollitropin(FSH-CTP) Alfa for Ovarian Stimulation in Donors

Start date: May 2016
Phase: Phase 4
Study type: Interventional

Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th stimulation day until ovulation induction with a bolus of another injection of a gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception, avoiding the LH surge. It has been described the usefulness of orally administered medroxyprogesterone acetate, 10 mg to inhibit the endogenous LH surge in IVF patients during COS. In donors, by administering a single injection of FSH-CTP and oral desogestrel since the first menstruation day, the total number of injections administered is reduced and less discomfort is experienced without adverse impact on ovarian response. No description of the hormonal and ovarian response under this protocol has been published

NCT ID: NCT02704936 Withdrawn - Primary Infertility Clinical Trials

Analysis of Lipid Profiles in Samples Sperm and Seminal Plasma Under Artificial Insemination

Start date: December 2015
Phase:
Study type: Observational

Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm and seminal plasma linking the success or failure of the artificial insemination (IUI)

NCT ID: NCT02605356 Withdrawn - Multiple Myeloma Clinical Trials

Phase 1b/2 Study Testing Radium-223 Dichloride/Bortezomib/Dexamethasone Combination in Relapsed Multiple Myeloma

Start date: October 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study will be conducted in 2 parts. The phase 1b part will be an international, phase 1b, open-label, dose-escalation assessment of radium-223 dichloride administered with bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary endpoint of the phase 1b part is to determine the optimal dose of radium-223 dichloride in combination with bortezomib/dexamethasone for the Phase 2 portion of the study. The phase 2 part will be an international, phase 2, double-blind, randomized, placebo-controlled assessment of radium-223 dichloride versus placebo administered with bortezomib and dexamethasone, in subjects with relapsed multiple myeloma. Randomization (1:1) in the phase 2 part will be stratified by: - Prior bortezomib treatment (yes, no) - Prior treatment (1 prior line of treatment, >1 prior line of treatment) Approximately 30 subjects (10 subjects per cohort) will be enrolled in the phase 1b part of the study and approximately 196 subjects will be enrolled in the phase 2 part of the study.

NCT ID: NCT02578134 Withdrawn - Clinical trials for Plantar Heel Pain, Plantar Fasciosis

US-guided Percutaneous Electrolysis (EPE®) in Plantar Fasciosis

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

Scientific evidence of conservative management of individuals with plantar fasciosis is sometimes conflicting. There is evidence that regular exercise programs are effective for this pain condition. The inclusion of other therapeutic modalities is still controversial. Some authors have suggested that the use of US-guided percutaneous electrolysis (EPE®) maybe useful for the management of chronic tendinopathies; however, no study has investigated the potential placebo effect of this intervention. The objective of this randomized clinical trial is to determine the effectiveness of US-guided percutaneous electrolysis (EPE®) versus sham US-guided percutaneous electrolysis for the management of patients with plantar fasciosis for pain, function, and disability.

NCT ID: NCT02566551 Withdrawn - Clinical trials for Benign Prostatic Hyperplasia

Prospective Controlled Randomized Study of PAE vs TURP for BPH Treatment.

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

The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) and the improvement of QoL, in patients undergoing prostatic artery embolization (PAE) or conventional transurethral resection of the prostate (TURP).

NCT ID: NCT02557412 Withdrawn - Sleep Apnea Clinical Trials

Effect of Nasal CPAP on Lipid Profile in Patients With Dyslipidaemia and Sleep Apnea

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

OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with conventional treatment, improves the lipid profile of patients with dyslipidemia and mild-moderate apnea-hypopnea syndrome (OSA). Secondary objectives: - Determine the additional effect of CPAP on insulin resistance and dyslipidemia in patients with mild-moderate OSA. - Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with dyslipidemia and mild-moderate OSA. DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional treatment. STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and in stable treatment during the last month with diet, cholesterol lowering drug, and cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics. Sample size. 38 patients who completed the test in each treatment arm. TREATMENT Patients will be randomized to one of the following treatment arms form: 1. hygiene and dietary recommendations. 2. lifestyle intervention (more strict and promotion of daily physical activity and dietary control). 3. Treatment with positive airway pressure (CPAP). ENDPOINTS: Efficacy endpoints. - Primary endpoint: LDL-cholesterol. - Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high sensitivity (hsCRP). - Systemic Biomarkers: inflammatory (IL-6, IL-8 and tumor necrosis factor (TNF)-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, vascular cell adhesion molecule 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1)), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A / hypocretin-1 and ghrelin). - Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and Homeostasis Model Assessment (HOMA) index and quantitative insulin sensitivity check index (QUICKI), thyroid-stimulating hormone (TSH). - Clinical questionnaires: short-form (SF)-12, EuroQoL, Functional Outcomes of Sleep Questionnaire (FOSQ) and International physical activity questionnaire (IPAQ). Security endpoints. - Notification of clinical adverse events. - Compliance with CPAP (average hours use per day). - Epworth Sleepiness Questionnaire. - Development of cardiovascular events.

NCT ID: NCT02552862 Withdrawn - Clinical trials for Spontaneous Bacterial Peritonitis

Study of the Effect of Adjunctive Vivomixx® in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP)

Start date: September 2016
Phase: Phase 3
Study type: Interventional

Study Design: Double-blind placebo-controlled clinical trial Study Duration:2 years Study Center: Hospital de la Santa Creu i Sant Pau, Barcelona (single center) Objectives: To assess the effect of adjunctive Vivomixx® on bacterial translocation in patients with cirrhosis and SBP Number of Subjects: 30 Main Inclusion Criteria: Patients with cirrhosis hospitalized with an episode of SBP at Hospital de la Santa Creu i Sant Pau Study Product, Dose, Route, Regimen: Vivomixx ® sachets containing 450 x 109 bacteria, 2 every 12 hours during hospitalization (n=15), or placebo (n=15) Duration of administration: During hospitalization due to SBP episode Hypothesis: The adjunctive treatment with Vivomixx® in patients with cirrhosis and SBP could decrease bacterial translocation and systemic and cerebral proinflammatory state. This would result in a faster SBP resolution, a decrease in the incidence of complications and an improvement in cognitive function.

NCT ID: NCT02397395 Withdrawn - Clinical trials for End-stage Renal Disease

An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.

Start date: May 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)

NCT ID: NCT02368990 Withdrawn - Clinical trials for Non Small Cell Lung Cancer

T790M Mutation Positive 2nd Line STandard of cAre Registry

T-STAR
Start date: June 2015
Phase: N/A
Study type: Observational

The aim of the study is to collect real world information on patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin /Carboplatin).