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NCT ID: NCT02366169 Recruiting - Clinical trials for Gastroesophageal Reflux Disease (GERD)

Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

Start date: March 2015
Phase: N/A
Study type: Observational [Patient Registry]

This registry is intended as an observational, post-marketing surveillance tool. The registry allows collection of baseline demographics and user experience of the commercially available MUSE system. Data collection aims to aggregate a minimum of 3 years follow-up on a large number of subjects during use outside the constraints of a prescribed clinical study.

NCT ID: NCT02365831 Recruiting - Clinical trials for Metastatic Breast Cancer

Observation of Medical Treatments in MBC HER2-negative Patients

AMBRA
Start date: May 2015
Phase: N/A
Study type: Observational

While therapeutic strategies for HER2-positive breast cancer are well defined, there is not a standard strategy for HER2-negative tumors. Because of lack of information related to the the factors affecting the choice of a particular treatment strategy, as well as the optimization of the correct sequence of treatments, the choice of the treatment for the advanced disease remains highly empirical and may differ significantly among the different cancer centers. The purpose of this study is the observation of a cohort of patients with metastatic HER2-negative in terms of: 1. the choice of chemotherapy treatments starting from the first line of treatment; 2. factors that may influence these choices; 3. correlation among the characteristics of patients (age, menopausal status, etc.) and type of adjuvant and metastatic treatment ; 4. clinical outcome (pattern of relapse, time from diagnosis, etc.); 5. evaluation of the adherence to the literature's recommendations for therapeutic sequences in clinical practice.

NCT ID: NCT02365740 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Postprandial Blood Glucose Control and Gastric Emptying in Type 1 Diabetes: Pathogenetic Factors and Therapeutic Options

Start date: November 2014
Phase: N/A
Study type: Interventional

This study evaluates the prevalence of gastric emptying (GE) in type 1 diabetic patients (DM1) free of chronic complications in comparison with a group of healthy control subjects. The investigators will also assess the relationship between GE and glucose control (HbA1c, postprandial glucose variability), gut peptide hormones (GLP-1, GIP, and ghrelin), and gastrointestinal symptoms. In addition, in patients with delayed GE the investigators will investigate the effect of "tailored" pre-prandial insulin bolus administered by means of insulin pump in reducing postprandial glucose variability, evaluated through continuous glucose monitoring system.

NCT ID: NCT02361905 Recruiting - Fibroid Clinical Trials

Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas

Start date: February 2015
Phase: Phase 4
Study type: Interventional

Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular than the surrounding myometrium, often with crowding and overlapping of nuclei. they often are soft and appear more tan or yellow and less circumscribed than the usual leiomyomas. Pre-operatively CLs can be recognized at ultrasound evaluation because they appear as hypoechoic uterine lesions. patients with hypoechoic myoma have a significantly longer surgery time after treatment with a gonadotropin-releasing hormone (GnRH) analog probably related to degenerative changes induced by this treatment. Hypoechoic CLs should be more responsive to ulipristal acetate treatment than common leiomyomas. The antiproliferative ulipristal effect, moreover, induces a condition of apoptotic necrosis that, compared to GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of the tumor.

NCT ID: NCT02361892 Recruiting - Infertility Clinical Trials

The Effect of Ulipristal Acetate (UPA) on Women Ovarian Reserve

UPA_ovAge
Start date: February 2015
Phase: Phase 4
Study type: Interventional

The uterine leiomyoma is the most common female benign disease.UPA seems to be most effective for the medical management of fibroids and could be place as preoperative adjunct to surgery but also as medical therapy to avoid surgery. No data have been published about the effect of UPA on FSH (Follicle stimulating hormone) or AMH levels nor on ovarian antral follicle count (AFC) or vascularization indexes during and after treatment. Considering that in young women of reproductive age (under 40 years old), desiring pregnancy, UPA has been proposed to avoid or postpone surgery, also in a long-term administration program, data about its effect on women ovarian reserve are urgently needed. For these reasons, data on biochemical (AMH, FSH and E2) and 3D ultrasonographic (VI, Flow index, AFC) parameters of women treated by UP are needed to assess the effect of the drug in terms of ovarian reserve modification.

NCT ID: NCT02361879 Recruiting - Fibroid Clinical Trials

Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma

Start date: February 2015
Phase: Phase 4
Study type: Interventional

The uterine leiomyoma is the most common female benign disease. Submucosal fibroid are about 10%, they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and infertility. Hysteroscopic removal of submucosal myomas improves this conditions. GnRH analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer, but they are expensive, have potential side effects and lack a robust evidence base to support this practice. Ulipristal acetate treatment was able and faster to control in 90% of cases uterine bleeding associated with fibroids than GnRH agonists. UPA significantly improved quality of life and pain reduction.

NCT ID: NCT02359747 Recruiting - Single-Gene Disease Clinical Trials

Analysis of Human Genomic DNA in Embryo's Culture Media

Start date: January 12, 2020
Phase:
Study type: Observational

try to find genomic DNA in culture medium after the embryos develop on Day 3 and Day 5 also in single step culture media. using direct PCR Polymerase Chain Reaction and also WGA Whole Genome Amplification before PCR and sequencing of the samples to find the point mutation

NCT ID: NCT02358980 Recruiting - Multiple Myeloma Clinical Trials

Kidney Therapy for Free Light Chain Removal in Patients With Multiple Myeloma & Cast Nephropathy

KEEPER
Start date: July 2014
Phase: N/A
Study type: Observational

Hypothesis: Free light chain (FLC) removal haemodialysis will increase the rate of renal recovery in patients with cast nephropathy, severe renal failure and de novo multiple myeloma. This study will evaluate patients with multiple myeloma and severe renal failure treated with KIDNEY Therapy (previously called SUPRA HFR) to remove free light chains.

NCT ID: NCT02357563 Recruiting - Fibroid Clinical Trials

Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation

Start date: February 2015
Phase: Phase 4
Study type: Interventional

Submucosal fibroid grow inside the uterine cavity and are associated with menorrhagia, abnormal uterine bleeding (AUB) and infertility. Type II (G2) fibroids often require more surgeries due to their particular position in the myometrium. Surgery, moreover, should always be tailored, particularly in patients wishing to conceive, to preserve the integrity of the myometrium. Preoperative use of GnRH agonist appears to be relevant and beneficial in patients with submucous fibroids, but are associated with several side effects. the eighty percent of patients treated by UPA showed a clinically meaningful reduction of more than 25% in fibroid volume, and 50% of patients a reduction of 50%. fibroid volume reduction appeared to be maintained for 6 months after the end of UPA treatment

NCT ID: NCT02355119 Recruiting - Pancreatic Cancer Clinical Trials

Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer

GIP-2
Start date: January 2015
Phase: Phase 3
Study type: Interventional

Patients with resected pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine, the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan), the experimental arm. A total of 310 patients will be enrolled in about 50 Italian centers.