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NCT ID: NCT02378870 Terminated - Clinical trials for Prostate Cancer Metastatic

A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC

Start date: January 2015
Phase: Phase 2
Study type: Interventional

This phase IIb study is a randomized, double-blind, placebo-controlled multi-center study evaluating efficacy and tolerability of Osteodex of patients with metastatic castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known substances; dextran, alendronate and guanidine. The objective of the study is to evaluate the relative change of response markers to bone metabolism (B-ALP and S-P1NP) The following objectives will also be evaluated: overall survival, PSA response, other response markers related to bone metabolism (S-CTX and osteocalcin), safety, tolerability, pain and quality of life.

NCT ID: NCT02378233 Terminated - Lactation Clinical Trials

Iodine Status in Swedish Lactating Women - Effect of Iodine Supplementation in the Thyroid Function of Mother and Infant

Start date: October 2011
Phase: N/A
Study type: Interventional

The aim of the study is to measure urinary milk iodine concentration (MIC), iodine concentration (UIC), thyroid hormones (TSH, FT4) and thyroperoxidase antibodies (TPOab) in breast-feeding women, and UIC in their nursing infants to determine if the levels are adequate, and to see how they can be influenced by 150 ug daily iodine supplementation in breast-feeding women. The hypothesis is that there is a relative iodine deficiency in this sub-population - lactating women and nursing children-, and that this can be influenced by iodine supplementation. Adequate thyroid hormone and iodine levels are very important for small children, when the plasticity of the brain is greatest. This is as a prospective, double-blind, placebo-controlled study of 221 mothers and their infants. In parallel, 90 age-matched healthy non-pregnant women are recruited. Mothers are randomized to 150 µg/day iodide supplementation or placebo. Pregnant women are asked for participation on a visit in pregnancy week 37, at the mother health care (MVC) at Mölnlycke and Skövde. The study will run for approximately 3 months for each individual and begins by sampling A (UIC, TSH, FT4, TPOab) at week 37 of the pregnancy, when mothers also get randomized to 150 µg iodine or placebo. New sampling B (UIC, TSH, FT4, MIC ) is collected when the baby is 3 months old. Thereafter the study is completed. In parallel, 90 healthy non-pregnant, non-lactating women in the same age range are recruited and followed with UIC, TSH, FT4, TPOab for 6 months as a control group. In each case a simple questionnaire is filled and blood is also frozen for future analyses.

NCT ID: NCT02373397 Terminated - Clinical trials for Corneal Dystrophy, Epithelial Basement Membrane

Cacicol20® in Corneal Wound Healing and Nerve Regeneration After Phototherapeutic Keratectomy

CACICOL-PTK
Start date: March 2015
Phase: N/A
Study type: Interventional

The objective of this clinical study is to test the efficacy of CACICOL20® (RGTA OTR 4120) in improving wound healing and nerve regeneration in the anterior cornea, in a patient population undergoing therapeutic laser treatment for corneal dystrophy or recurrent corneal erosions.

NCT ID: NCT02360852 Terminated - Clinical trials for Biliary Cirrhosis, Primary

IBAT Inhibitor A4250 for Cholestatic Pruritus

Start date: January 2015
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability and influence on itching, bile acids and liver enzyme changes in patients with PBC (Primary Biliary Cirrhosis) treated with A4250

NCT ID: NCT02351089 Terminated - Gynecologic Cancer Clinical Trials

Probiotics in Radiation-treated Gynecologic Cancer

ProRad
Start date: February 2015
Phase: N/A
Study type: Interventional

The aim of the current Project is to study the efficacy of a probiotic Product in reducing the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer.

NCT ID: NCT02351063 Terminated - Heart Failure Clinical Trials

HF Assessment With BNP in the Home: Part II

HABIT-II
Start date: April 2014
Phase: N/A
Study type: Interventional

HABIT-II is a feasibility study aimed at home monitoring of patients with heart failure. B-type natriuretic peptide (BNP) has strong correlations to the severity of heart failure. Lower BNP levels are closely associated with better clinical outcomes. The goal of HABIT-II is to demonstrate that the results of daily patient self-testing of BNP at home will provide sufficient information to guide physicians to modify therapy and lower BNP levels over time.

NCT ID: NCT02346643 Terminated - Chronic Pain Clinical Trials

A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region

BINGO
Start date: April 2013
Phase:
Study type: Observational

11-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of intractable, chronic pain

NCT ID: NCT02342704 Terminated - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

REVEAL
Start date: November 2014
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to assess the effect of natalizumab compared to fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this study population are to assess the effect of natalizumab compared to fingolimod on: magnetic resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as measured by the number of new T1-Gd+ lesions; various other MRI measures of disease activity; No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The change in information processing speed as measured by the Symbol Digit Modalities Test (SDMT).

NCT ID: NCT02340221 Terminated - Breast Cancer Clinical Trials

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

SANDPIPER
Start date: April 9, 2015
Phase: Phase 3
Study type: Interventional

This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.

NCT ID: NCT02335723 Terminated - Septic Shock Clinical Trials

ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber

ASSET
Start date: September 2015
Phase: N/A
Study type: Interventional

The primary objective of this clinical investigation is to investigate the feasibility and possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with presumed endotoxemia of abdominal or urogenital origin.