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NCT ID: NCT02389842 Active, not recruiting - Breast Cancer Clinical Trials

PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib

PIPA
Start date: March 25, 2015
Phase: Phase 1
Study type: Interventional

Part A: This is a phase Ib trial combining the CDK4/6 inhibitor palbociclib with the PI3K inhibitors taselisib, or pictilisib. There are two treatment arms during the dose escalation phase where patients will receive either taselisib OR pictilisib in combination with palbociclib. Palbociclib, taselisib and pictilisib can all be given orally once daily with food, in a 21-days-on and 7-days-off schedule. Once the MTD is reached, the combination with the optimum safety and PK/PD profile will be taken forward to the dose expansion phase (Part B). Part B1: At the MTD dose expansion, fulvestrant will be administered in addition to palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on and 7-days-off schedule in the ER+ve HER2-ve PIK3CA mutant breast cancer cohort. Fulvestrant will be given intramuscularly on Day 1, Day 15 in cycle one followed by Day 1 for all subsequent cycles. Part B2: At the MTD dose expansion, patients with PIK3CA mutant advanced solid tumours will be treated with palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on and 7-days-off schedule.

NCT ID: NCT02388906 Active, not recruiting - Melanoma Clinical Trials

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

CheckMate 238
Start date: March 19, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

NCT ID: NCT02386553 Active, not recruiting - Clinical trials for Spinal Muscular Atrophy

A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy

NURTURE
Start date: May 18, 2015
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to examine the efficacy of multiple doses of Nusinersen administered intrathecally in preventing or delaying the need for respiratory intervention or death in infants with genetically diagnosed and presymptomatic spinal muscular atrophy (SMA). Secondary objectives of this study are to examine the effects of Nusinersen in infants with genetically diagnosed and presymptomatic SMA.

NCT ID: NCT02385214 Active, not recruiting - Clinical trials for Cutaneous Melanoma by AJCC V7 Stage

MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

MelMarT
Start date: January 3, 2015
Phase: Phase 3
Study type: Interventional

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with a primary invasive cutaneous melanomas >=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients

NCT ID: NCT02384213 Active, not recruiting - Heart Failure Clinical Trials

Incidence of and Prognostic Factors Associated With Heart Failure Following Myocardial Infarction: a CALIBER Study

iHF
Start date: March 2015
Phase: N/A
Study type: Observational

The main objectives of this study are: i) to investigate the incidence and prevalence of fatal and non-fatal heart failure (HF) following myocardial infarction (MI) and its evolution over time in men and in women; ii) to identify prognostic factors for developing HF in patients who had an MI.

NCT ID: NCT02383953 Active, not recruiting - Ulcerative Colitis Clinical Trials

SSAT 054: Non Genetic Factors in the Pathogenesis of IBD in Twins

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

This study aims to investigate the role of non-genetic factors in the pathogenesis of inflammatory bowel disease.An exploratory study to investigate differences between the epigenome, microbiota and functional immunology in twins discordant for inflammatory bowel disease.

NCT ID: NCT02379026 Active, not recruiting - Obesity Clinical Trials

Lifestyle Modifications for the Treatment of Sarcopenic Obesity

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

This study evaluates the addition of a high-protein energy-restricted diet to exercise in the treatment of sarcopenic obesity in people aged 65 and over. Half of participants will follow a hypocaloric (500 kcal deficit) high-protein (1.2 -1.5 g Protein/ kg bodyweight) diet alongside an exercise regime, while the other half will follow the same exercise regime alongside their habitual diet . All participants will consume a Vitamin D3 tablet (25micrograms) 3 times a week to achieve a weekly intake of 75 micrograms. Total duration of the intervention will be 16 weeks.

NCT ID: NCT02375204 Active, not recruiting - Germ Cell Tumor Clinical Trials

Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors

Start date: August 5, 2015
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

NCT ID: NCT02371382 Active, not recruiting - Clinical trials for Arthroplasty, Replacement, Hip

Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem

Sirius
Start date: March 2013
Phase:
Study type: Observational

The purpose of this multicentre, prospective study is: - Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3 years, 5 years, 7 and 10 years. - Report Safety and Survivorship up to 10 years F/up.

NCT ID: NCT02369731 Active, not recruiting - Clinical trials for Muscular Dystrophy, Duchenne

Registry of Translarna (Ataluren) in Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)

Start date: April 30, 2015
Phase:
Study type: Observational [Patient Registry]

This study is being performed as a post-approval safety study (PASS), per the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), to gather data on Translarna (ataluren) safety, effectiveness, and prescription patterns in routine clinical practice.