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NCT ID: NCT03790865 Terminated - Clinical trials for Prader-Willi Syndrome

Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome

ZEPHYR
Start date: March 25, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).

NCT ID: NCT03790332 Active, not recruiting - Clinical trials for Chronic Graft Versus Host Disease

Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

Start date: November 19, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)

NCT ID: NCT03790267 Completed - Clinical trials for Arthroplasty, Replacement, Knee

Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty

PaRIS-IOR
Start date: January 1, 2019
Phase:
Study type: Observational

PaRIS-IOR is a prospective observational study that aims to collect and analyze functional outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR).

NCT ID: NCT03790254 Completed - Clinical trials for Antibiotic Prophylaxis

D Mannose for Prevention and Treatment of RUTIs

mannoseRUTIs
Start date: January 1, 2010
Phase:
Study type: Observational

The aim of this review is to address clinical reliability, efficacy and safety of long-term treatment with oral D Mannose for the prevention of recurrent urinary tract infections (RUTIs) in females.

NCT ID: NCT03790189 Recruiting - Clinical trials for Osteoarthritis, Knee

Subchondral and Intra-articular Application of Bone Marrow Concentrate for Knee Unicompartmental OA

MarrowMule
Start date: January 2019
Phase: N/A
Study type: Interventional

Unicompartmental knee osteoarthritis (OA) is a common finding especially in patients with lower limb malalignment and previous meniscectomy. Among the various treatment options, in recent years there has been an increasing attention towards the use of biologic agents, such as platelet rich plasma and mesenchymal stem cells, as intra-articular injective approaches to relieve pain and restore joint function. Anyway, the sole intra-articular administration of these agents may not lead to satisfactory outcome in a relevant percentage of patients. In fact, unicompartmental osteoarthritis is not only characterized by degeneration of the articular cartilage, but also by pathologic changes in the subchondral bone, both at the tibial plateaux and in the femoral condyle. Magnetic resonance imaging reveals, in many cases, alterations of the subchondral tissue known as "bone marrow edema", which is a sign of bone overload and play a significant role in the progression of unicompartmental OA and is responsible of OA-related symptoms. Therefore, concurrent treatment of both the subchondral bone damage and intra-articular degeneration could led to better outcome for patients affected by unicompartmental OA: the aim of the present pilot trial is to assess the safety and describe the clinical outcome following concurrent intra-articular and subchondral bone application of Bone Marrow Concentrate (BMC). BMC is an autologous product rich in mesenchymal stem cells, which have immuno-modulatory and throfic properties and are able to restore the joint homeostasis by reducing the inflammatory distress traditionally associated to OA. BMC will be collected directly in the operating room from the anterior iliac crest or the tibia by using the MARROW CELLUTION kit (Geistlich, Switzerland), which allows to obtain BMC without the need of centrifugation processes. Approximately 9-10 ml of BMC will be harvested: 6 ml will be injected, under fluoroscopic guidance, in the tibial emiplateaux (approx 3 ml) and in the femoral condyle (approx 3 ml) presenting MRI evidence of bone marrow edema. The remaining amount of BMC will be administered intra-articularly to address articular tissues (cartilage, menisci and synovium). Twenty-five patients affected by unicompartmental knee OA will be included in the present pilot trial and treated in a "Day-Surgery" regimen. They will be followed up at 3, 6, and 12 months' after treatment by clinical questionnaires and radiographic evaluations (x-rays at 6 and 12 months, MRI at 12 months' f-up). Any intra-op and post-op adverse events will be documented.

NCT ID: NCT03789981 Recruiting - Clinical trials for Acute Myeloid Leukemia

Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia

Immune-AML
Start date: July 19, 2019
Phase:
Study type: Observational

This is a multicenter, prospective, translational study, to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.

NCT ID: NCT03789916 Recruiting - Clinical trials for Coronary Artery Disease

SAPT Versus DAPT in Incomplete Revascularization After CABG

SDAT-IRC
Start date: January 2, 2019
Phase: Phase 3
Study type: Interventional

The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG). Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.

NCT ID: NCT03789656 Completed - Acromegaly Clinical Trials

An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

Start date: January 15, 2019
Phase: Phase 2
Study type: Interventional

An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.

NCT ID: NCT03789435 Completed - Clinical trials for Lower Limb Amputation Below Knee

Pain in Trans Femoral and Trans Tibial Amputees

AMPUPHANTOM
Start date: March 7, 2019
Phase:
Study type: Observational [Patient Registry]

Phantom limb is difficult to manage and has a significant impact on the patient's quality of life. At present, the scientific evidence shows that the infusion of local anesthetics with epidural and perineural catheters in the perioperative phase correlates with good pain control in the immediate post-operative, expressed in terms of reduced demand for opiates by the patient undergoing amputation. of lower limb. Few are studies that highlight the effectiveness of such treatments in the medium and long-term prevention of phantom limb syndrome. The study aims to evaluate the incidence in the medium term of the phantom limb in trans femoral and trans tibial amputees and the possible relationship with the use of adequate pre and perioperative analgesia using peridural and peripheral nerve catheters. The results of the study could provide indications about the need to modify both the perioperative analgesic therapy protocol and also rehabilitation for lower limb amputation surgery in order to reduce the prevalence of phantom limb syndrome with consequent improvement in quality of life.

NCT ID: NCT03788720 Not yet recruiting - Endometrioma Clinical Trials

Suture of the Ovary After Enucleation of Ovarian Endometrioma

SOAVE-1
Start date: May 2023
Phase: N/A
Study type: Interventional

Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity. According to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed directly to Assisted Reproduction Technology (ART); conversely, for infertile women with endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in order to improve reproductive outcomes (both spontaneous and ART pregnancy rate). To date, literature data do not allow to draw a firm conclusion about the best strategy to reduce ovarian damage during enucleation of ovarian endometriomas: in particular, investigators still lack robust evidence in order to choose between suturing the ovary or not after the enucleation. In this scenario, the aim of our the study will be to compare functional outcomes of the ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.