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NCT ID: NCT01684878 Completed - Ovarian Cancer Clinical Trials

Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)

Start date: October 2012
Phase: Phase 3
Study type: Interventional

This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).

NCT ID: NCT01684566 Completed - Oral Mucositis Clinical Trials

A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis

episil(R)
Start date: February 2013
Phase: N/A
Study type: Interventional

To compare the performance of standard of care (SOC) + episil® versus SOC alone on oral mucositis in patients receiving conditioning treatment for hematopoietic stem cell transplantation (HSCT). The primary variable will be the area under the curve (AUC) of oral mucositis scores defined by the World Health Organisation (WHO) oral toxicity scale assessed daily by the investigator over the 28-day study period.

NCT ID: NCT01683266 Completed - Clinical trials for Type 1 Diabetes Mellitus

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

EDITION IV
Start date: September 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: - To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus Secondary Objective: - To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of: - Change of HbA1c from baseline to endpoint (scheduled Month 6) - Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM) - Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia) - Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative) - Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period

NCT ID: NCT01682967 Completed - Clinical trials for Parturients in Labour

Alteration in Hearing Following Accidental Dural Puncture. A Study in Parturients

AHEAD
Start date: January 2012
Phase: N/A
Study type: Observational

Headache following accidental dural punction as during epidural analgesia can be severe and sometimes very disabling. The incidence of PDPH is 10-40%, most starting within 48 h of dural puncture. Although spontaneous resolution of headaches is common in most patients within 7 days, in 20% can they be persistent and in some very disabling. The exact reason for the characteristic headache is unknown, but it is believed to be the result of leakage of cerebro-spinal fluid (CSF) from the dural puncture. The greater the leakage of CSF, the more severe and persistent the headache. This is why larger needles (lower gauge) are known to have a higher incidence of PDPH. However, the type of needle also seems to play an important role in the likelihood of PDPH. Headache following accidental PDPH is very typical as it increases significantly when sitting or standing and often disappears completely on lying down. It is typically located in the back of the head, accentuated by light and often decreases with intake of large quantity of fluids. In many cases, it is self-limiting and most often decreases with time and bed rest. Diagnosis of PDPH is clinical and sometimes difficult. It is well known that liquor leakage, as following spinal anaesthesia, results in partial loss of unilateral or bilateral hearing that can be detected by oto-acoustic hearing loss. We plan to use this knowledge and test the hypothesis that measurement of hearing loss may be a diagnostic method for confirmation of clinical symptoms and signs of accidental PDPH.

NCT ID: NCT01682720 Completed - Hepatitis C Clinical Trials

Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

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

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

NCT ID: NCT01682486 Completed - Clinical trials for Hospital Acquired Infections

BIP ETT Clinical Tolerability, Safety and Performance Study

BIPETT
Start date: April 2012
Phase: N/A
Study type: Interventional

The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s tolerability, safety and performance and compare it to a standard un-coated Endotracheal tube.

NCT ID: NCT01682083 Completed - Melanoma Clinical Trials

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

COMBI-AD
Start date: January 8, 2013
Phase: Phase 3
Study type: Interventional

This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.

NCT ID: NCT01681771 Completed - Heart Failure Clinical Trials

Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression

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

The purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in patients with chronic heart failure and depression.

NCT ID: NCT01681472 Completed - Colonic Neoplasms Clinical Trials

PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer

Start date: September 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to compare the concentration of four different metabolites in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different doses of Modufolin (arfolitixorin) and Levoleucovorin (Isovorin®), respectively (60 and 200 mg/m2).

NCT ID: NCT01681290 Completed - Clinical trials for Diabetic Peripheral Neuropathy

Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type 1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy (DPN).