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NCT ID: NCT01689454 Enrolling by invitation - Infertility Clinical Trials

ISM1 Versus EmbrioGen Media for Embryo Culture With Previous Failure Implantation in ART Treatments

Start date: September 2012
Phase: Phase 3
Study type: Observational

Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss. Couples requiring IVF treatment and with a past experience of implantation failure will be included in the study. Controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2 atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv, Denmark) will be adopted throughout the culture period. In the control group, inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio, Måløv, Denmark), maintaining unchanged all other culture conditions. Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1 respectively. The endometrial support will be the same in the two groups.

NCT ID: NCT01689428 Enrolling by invitation - Infertility Clinical Trials

Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases

Start date: September 2012
Phase: Phase 3
Study type: Observational

Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss. Couples requiring IVF treatment and with a past experience of miscarriage and/or biochemical pregnancy will be included in the study. Controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2 atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv, Denmark) will be adopted throughout the culture period. In the control group, inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio, Måløv, Denmark), maintaining unchanged all other culture conditions. Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1 respectively. The endometrial support will be the same in the two groups. The investigators will consider ongoing clinical pregnancy as the primary outcome assuming a 25% of increment in ongoing clinical pregnancy rate in the group with EmbryoGen medium. As secondary outcome the investigators will assume a 5% of increment in ongoing implantation rate after 12 weeks in the group with EmbryoGen medium.

NCT ID: NCT01467960 Enrolling by invitation - Parkinson's Clinical Trials

Apolipoprotein D (ApoD) In Human Serum As Marker Of Parkinson's Disease

ApoD
Start date: November 2011
Phase: N/A
Study type: Observational

In Italy affected people are 200,000 and every year Parkinson new cases are 10,000. Aging is the principle risk factor of Parkinson with the possibility of its development doubling every five years after 65. Because of the increase of the social longevity and aging as the main risk factor, there are many repercussions on the health system (hospital stays and pharmaceutical costs) as on the social system (assistance- related problems). Parkinson's disease exerts an extremely negative impact on life's quality of the patient. In fact, because of Parkinson symptoms (tremor, dribble, etc), patient's social life will be reduced with the consequent development of the depression. Consequently, the early detection and treatment of Parkinson's is necessary. To achieve this goal, Apolipoprotein D (ApoD) in human serum as a marker of the oxidative stress-inflammation vicious cycle seems most promising candidate for diagnosis.

NCT ID: NCT01397682 Enrolling by invitation - Aging Clinical Trials

Epidemiological Observatory on the Health Conditions of Inpatients Aged 65 or Older at the INRCA Research Hospitals

report-AGE
Start date: May 5, 2011
Phase:
Study type: Observational

The goal of this research study is to collect clinical data, comprehensive geriatric assessment, risk factors, biological data and blood samples from inpatients aged 65 and older at the INRCA research hospitals (Italy). All data will be stored in a research bank and used to better clarify the mechanisms underlying the condition of "frailty" in aged patients. The database will be created on the INRCA server platform by establishing a safe HTTPS protocol.

NCT ID: NCT01259167 Enrolling by invitation - Low Back Pain Clinical Trials

JOBA & Chronic LOw BAck Pain JOBA® & Chronic LOw BAck Pain JOBA® & Chronic LOw BAck Pain JOBA® & Chronic LOw BAck Pain

JOBA-Loba
Start date: January 2011
Phase: N/A
Study type: Observational

The purpose of this study was to assess whether a training program based on Joba® Core Trainer is effective in reducing pain and improving physical function and quality of life of subjects suffering from Chronic Low Back Pain.

NCT ID: NCT01157507 Enrolling by invitation - Clinical trials for Painful Bladder Syndrome (PBS)

Botulinum A Toxin in the Treatment of Patients With Painful Bladder Syndrome

Start date: January 2010
Phase: Phase 4
Study type: Interventional

Previous clinical observations showed that Botulinum A toxin (BoNT/A) has also an antinociceptive effect and can control the neuropathic pain. In the urologic field, recent in in vitro and in in vivo studies demonstrated that the neurotoxin is able to inhibit the release of several neurotransmitters from the bladder afferent fibers and urothelium. These neurotrasmitters as SP, CGRP, ATP, NGF and Prostaglandins are involved in neurogenic inflammation. Thus, it is reasonable to hypothesize that patients with affected by painful bladder syndrome (PBS) could benefit from BoNT/A intravesically administered. The aim of the study is to investigate the clinical and urodynamic effects of an intravesical treatment with BoNT/A in patients affected by PBS associated with increased urinary frequency, who are refractory to conventional treatments. This treatment will be compared to bladder over distention, which is considered a conventional therapy.

NCT ID: NCT01067625 Enrolling by invitation - Obesity Clinical Trials

Endoscopic Bariatric Stapling Pilot Study

TOGA®
Start date: February 2006
Phase: Phase 1
Study type: Interventional

This study is a prospective single-arm, multicenter study to evaluate the safety and effectiveness of the TOGA® Procedure for the treatment of morbid obesity.

NCT ID: NCT00951288 Enrolling by invitation - Clinical trials for Age-Related Macular Degeneration

Effect of Saffron Supplementation on Macular Cone-mediated Function in Age-related Macular Degeneration

safAMD
Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This is a pilot interventional study whose aim is to determine the effect of a dietary supplementation with a Crocus Sativus extract, Saffron, on macular cone-mediated function in patients with early age-related macular degeneration (AMD). Pre-clinical evidence ( Maccarone R, Di Marco S, Bisti S. Saffron supplement maintains morphology and function after exposure to damaging light in mammalian retina. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):1254-61.) indicates the potential effectiveness of Saffron as a retinal neuroprotectant in animal models of retinal degenerative disorders.The macular function will be tested by visual acuity and macular cone-mediated electroretinogram (focal electroretinogram, FERG) according to a standardized technique (see citations).

NCT ID: NCT00928603 Enrolling by invitation - Prostate Cancer Clinical Trials

Investigative Study of the Role of Focal Therapy for Prostate Cancer Treatment

Start date: September 2009
Phase: Phase 1
Study type: Interventional

Surgery and irradiation for organ confined prostate cancer provide excellent long-term cancer control but they may be accompanied by a risk of side effects that decrease quality of life. Due to the stage migration of prostate cancer, the potential for patients to undergo unnecessary treatment and the risk of treatment related morbidity, has been increased.Alternative strategies that offer the possibility of delaying, obviating or minimizing the impact of treatment maintaining the same oncological long term results have been investigated. Despite pros and cons active surveillance has not gained popularity in men with low risk prostate cancer as only 7% of men with localized prostate cancer remain in active surveillance. Traditionally solid tumors have been treated with radical surgery but selective, organ sparing therapies are now common for tumors of the breast, skin and kidney, resulting in equivalent rates of cancer control, lower morbidity rates and less disfigurement. With this in mind the potential role of focal ablative therapy for localized prostate cancer might be considered. The researchers will investigate the feasibility and the efficacy in term of quality of life and oncologic results of focal therapy by a pilot not randomized prospective study in a patients with localized prostate cancer who meet low risk criteria based on clinical, biopsy and imaging data.

NCT ID: NCT00848198 Enrolling by invitation - Dry Eye Disease Clinical Trials

TearLab Core Validation Study

CVS
Start date: February 2009
Phase: N/A
Study type: Observational

This is a global study of tear osmolarity using the OcuSense TearLab technology to compare tear samples of age and sex-matched normals with those with Dry Eye Disease (DED). Diagnosis of DED subjects will be established using objective and subjective tests. Positive responses to 3 out of 6 defined criteria determine subjects with DED. DED subjects will be further categorized by severity, using results from the objective and subjective tests. Subjects will be assessed at a single visit.