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NCT ID: NCT02443155 Completed - Diabetes Clinical Trials

A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

Start date: November 10, 2015
Phase: Phase 2
Study type: Interventional

This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.

NCT ID: NCT02442895 Completed - Pregnancy, Ovarian Clinical Trials

Biomarkers of Ovarian Reserve and Correlation With IVF Treatments

Start date: February 2014
Phase: N/A
Study type: Observational

Retrospective study to evaluate the correlation between AFC, FSHb, AMH and IVF outcomes of 347 cycles performed with three different protocols.

NCT ID: NCT02441946 Completed - Breast Cancer Clinical Trials

A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

neoMONARCH
Start date: August 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.

NCT ID: NCT02441543 Completed - SOLID TUMOR Clinical Trials

Regulation of Lymphocyte Anti-tumor Response in Metastatic Patients Treated With the mTOR Inhibitor Everolimus

Start date: April 2015
Phase:
Study type: Observational

Preclinical studies and clinical observations have shown the Phosphoinositide 3-kinase (PI3K) /Protein kinase B (AKT) /mammalian (mechanistic) target of Rapamycin (known as the 'mTOR-pathway') signaling to be deregulated in several tumors.

NCT ID: NCT02439489 Completed - Solid Tumors Clinical Trials

Study of the Combination of BKM120 and Cisplatin or Carboplatin in Patients With Advanced Solid Tumors

Start date: December 2012
Phase: Phase 1
Study type: Interventional

PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of PI3K (e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive towards PI3K-pathway inhibition. BKM120 is a potent and highly specific oral pan-class I PI3K-inhibitor. The study FM-11-F01b is a phase Ib single institution study using the combination of BKM120 and cisplatin or carboplatin in patient with pathologically confirmed recurrent or metastatic advanced solid tumor, for which treatment with a platinum agent is indicated (preferentially head and neck, NSCLC, ovary, endometrial). The primary objective of the study is to define the phase II recommended dose of daily oral BKM120 and cisplatin (Group 1) or carboplatin (Group 2), given intravenously (IV) on day 1 every 3 weeks.

NCT ID: NCT02438826 Completed - Clinical trials for Chronic Cluster Headache

A Study of Galcanezumab in Participants With Chronic Cluster Headache

Start date: June 18, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.

NCT ID: NCT02437929 Completed - Pain Clinical Trials

Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment

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

This study aims to assess self reported procedural pain compared with background pain and evaluate pain intensity differences across six standard procedures. Besides, rescue and preventive treatments used to control procedural pain will be examined.

NCT ID: NCT02437591 Completed - Clinical trials for Inflammatory Bowel Disease (IBD)

Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

PROFILE
Start date: August 13, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI). This study will also compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. difficile total viable count and spore count during treatment with FDX and if achieved; the time to microbial eradication; determine time to negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving FDX; record the incidence and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.

NCT ID: NCT02437318 Completed - Breast Cancer Clinical Trials

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

SOLAR-1
Start date: July 23, 2015
Phase: Phase 3
Study type: Interventional

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

NCT ID: NCT02436668 Completed - Clinical trials for Metastatic Pancreatic Adenocarcinoma

Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)

Start date: May 2015
Phase: Phase 3
Study type: Interventional

This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma.