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NCT ID: NCT02616744 Completed - Breast Cancer Clinical Trials

Study of Oral Bisphosphonate for Osteopenic Women Treated With Adjuvant Aromatase Inhibitors

BONADIUV
Start date: January 2011
Phase: Phase 2
Study type: Interventional

A single--blind, randomized, placebo--controlled phase II study to evaluate the impact of oral bisphosphonate treatment on bone mineral density in osteopenic women receiving aromatase inhibitors as adjuvant treatment.

NCT ID: NCT02616029 Completed - HIV-1 Infection Clinical Trials

Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I

Start date: December 17, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) after switching from a stable regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral (ARV) agent in participants harboring the archived nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or M184I in human immunodeficiency virus (HIV) -1 reverse transcriptase. This is a two part study. If the rate of virologic failure in Part 1 is deemed acceptable, once the internal data monitoring committee officially completes the interim review, the study will continue to Part 2.

NCT ID: NCT02615665 Completed - Clinical trials for Colorectal Liver Metastases

Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Metastases

Start date: January 2013
Phase: N/A
Study type: Observational

The long-term outcome of patients resected for colorectal liver metastases (CLM) after neoadjuvant chemotherapy (CHT) depends by several tumoral and non-tumoral factors, such as the immune response to the tumor and to the CHT. The aim of this study was to investigate the impact of the pathological and immunological response in patients undergoing liver resection for CLM after CHT in regards to the long-term outcome.

NCT ID: NCT02615496 Completed - Clinical trials for Macular Degeneration

Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept

Start date: December 7, 2015
Phase: N/A
Study type: Observational

The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five European countries.

NCT ID: NCT02615249 Completed - Clinical trials for Dermatitis, Eczematous

Clinical Evaluation of Metal Panel Allergens: Dose Response Study

Start date: December 5, 2016
Phase: Phase 2
Study type: Interventional

48-hour application of metal allergen patches to test for potential allergic responses.

NCT ID: NCT02614794 Completed - Clinical trials for HER2 Positive Breast Cancer

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

HER2CLIMB
Start date: January 28, 2016
Phase: Phase 2
Study type: Interventional

This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo. The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.

NCT ID: NCT02614391 Completed - Pain Relief Clinical Trials

Tablet Distraction for Pain Control During Venipuncture

Start date: March 2013
Phase: Phase 3
Study type: Interventional

Venipuncture is one of the painful procedures most frequently performed in children. Pain and distress management in children, during needle related procedures, is warranted. The base for pain management starts with behavioural and environmental support and distraction. Distraction is a cognitive strategy trying to divert the child's attention from a noxious stimulus. Active distraction involves the child in a different performance, e.g. playing, during pain procedures. Passive distraction redirects the child's attention to visual or auditory stimuli using toys, songs, movies or blowing bubbles. Blood-drawing centre is a peculiar setting in which many procedures have to be performed in a limited time. Patients usually arrive without a pharmacological premedication and go away immediately after procedure. In this context distraction is an excellent pain relief tool. The aim of the study is to compare the effectiveness of an active distraction (playing a videogame using a computer tablet) with a passive distraction technique in pain relief during venipuncture in a blood-drawing centre.

NCT ID: NCT02614261 Completed - Chronic Migraine Clinical Trials

Evaluation of Galcanezumab in the Prevention of Chronic Migraine

REGAIN
Start date: November 30, 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 migraine.

NCT ID: NCT02613039 Completed - Clinical trials for Mental Health Wellness 1

Oral Contraceptive Therapy and Sexuality

COSEX
Start date: October 2015
Phase: Phase 4
Study type: Interventional

Oral contraceptives (OCs) ameliorate hyperandrogenism and regulate menstrual cycles. To reduce androgenic side effects of first- and second-generation progestins, several new progestins derived from progesterone or spironolactone have been developed in the last few decades. These progestins, such as drospirenone, cyproterone acetate and NOMAC, are designed to bind specifically to the progesterone receptor and to have no androgenic, estrogenic or glucocorticoid actions. However, OCs with a more pronounced anti-androgenic effects are more likely to induce sexual dysfunction, mainly hypoactive sexual desire disorder, which can highly impact patient and partner's quality of life. Moreover, available data indicate that OC use might increase adiposity in adolescents and might be associated with central redistribution of body fat in young women with Polycystic ovary syndrome (PCOS) without a recognizable difference in clinical anthropometric measurements, including body mass index and waist circumference. In this context, it would be worth to evaluate the effects of combined OCs on metabolic and sexual health (sexual desire, arousal, and other parameters of sexual health), body image and mood.

NCT ID: NCT02612532 Completed - Lung Cancer Clinical Trials

Lung Cancer Indicator Detection

LuCID
Start date: October 7, 2015
Phase: N/A
Study type: Interventional

The Lung Cancer Indicator Detection (LuCID) study investigates the the diagnostic accuracy of FAIMS for diagnosis of lung cancer by analysis of exhaled Volatile Organic Compounds.