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NCT ID: NCT03197987 Completed - Adenomatous Polyps Clinical Trials

Comparison of Two Devices During Colonoscopy

COLONAUX
Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy. In this study we compare two devices: Endocuff (TM) and cap that can increase the adenoma detection rate during colonoscopy.

NCT ID: NCT03197935 Completed - Clinical trials for Triple-negative Breast Cancer

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

IMpassion031
Start date: July 24, 2017
Phase: Phase 3
Study type: Interventional

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

NCT ID: NCT03197766 Completed - Achondroplasia Clinical Trials

A Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia

Start date: December 12, 2016
Phase: Phase 3
Study type: Interventional

The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia.

NCT ID: NCT03197714 Completed - Clinical trials for Acute Myeloid Leukemia

Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia

Start date: September 7, 2017
Phase: Phase 1
Study type: Interventional

Phase Ib, open-label, dose-escalation clinical trial to evaluate the best-tolerated doses in Acute Myeloid Leukaemia (AML) relapsed or refractory to chemotherapy. This open-label, nonrandomized trial will comprise 2 stages. A dose escalation stage will characterize the safety, tolerability and maximum tolerated dose (MTD), of OPB-111077. Subsequently, an expansion stage will further evaluate the safety and antitumor activity of OPB-111077 in AML relapsed or refractory to chemotherapy. Enrollment to the expansion cohort will begin following determination of the MTD. Approximately 6-12 patients will be included in the phase I part of this clinical trial. Additional patients will be included in the expansion cohort up to a total of 15 patients. The expansion cohort will serve to further evaluate safety simultaneously with preliminary efficacy. Patients will be selected and included in the study after testing the response to the drug with the Vivia Biotech ex vivo CDx PharmaFlow PM test. PharmaFlow PM test is a companion diagnostic (CDx) tool that provides a complete pharmacological profile for each individual, allowing the detection of patients resistant to OPB-111077 and enriching the study in patients that respond to the drug. The third of patients more sensitive to OPB-11077 wil be included in the study.

NCT ID: NCT03197519 Completed - Eating Disorder Clinical Trials

Evaluation of a Program for Eating Disorders That Combines Cognitive-behavioral Therapy With Online Psychological Treatment

Start date: September 4, 2017
Phase: N/A
Study type: Interventional

The purpose of this project is to conduct a multicentre, randomized controlled trial (RCT) with 250 patients diagnosed with an eating disorder (ED). In this experiment, the patients from the experimental group will test an mHealth application (TCApp developed by HealthApp) and then, a clinical efficacy analysis and economic evaluations will be performed. To do this, we have set the following three specific objectives: - To evaluate the clinical efficacy of an intensive intervention that includes both standard face-to-face Cognitive Behavioural Treatment (CBT) (treatment as usual, TAU) plus an online intervention using TCApp, versus TAU alone. - To carry out an economic evaluation (cost-utility and cost-effectiveness analysis) of the new mHealth intervention and identify factors that promote or hinder the implementation of TCApp in mental health settings in Spain. - To analyse the adoption processes of this type of applications by patients and health professionals and identify the determinants of mHealth adoption. General hypothesis: The implementation of the intensive intervention program (TAU + TCApp) would result in a more significant improvement of the ED symptoms compared to the TAU control group. Specific hypotheses: - The application of the intensive mHealth intervention would lead to significantly greater change scores (difference between T0 and T1) in the primary outcome variable of ED psychopathology, compared to the control group. - The mHealth intervention would lead to significantly greater change scores (difference between T0 and T1) in patients' secondary outcome variables: a) depression symptoms, b) anxiety symptoms, c) motivation to change, d) suicidal risk, and e) quality of life, compared to the control group. - Similarly, intensive intervention would result in greater change scores (difference between T0 and T1) in caregivers' variables: a) quality of life and b) caregiver burden.

NCT ID: NCT03197285 Completed - Neck Pain Clinical Trials

Effectiveness of an Eye-Cervical Re-education Program in Chronic Neck Pain

Start date: June 2012
Phase: N/A
Study type: Interventional

The aim of the present study is to value the effectiveness of an Eye-Cervical Re-education Program (ECRP) to decrease pain and increase mobility in the cervical area compared to a Combined Physiotherapy Protocol (CPP) in patients with chronic neck pain symptoms.

NCT ID: NCT03196973 Completed - Clinical trials for Acute Otitis Externa

Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa

Start date: July 22, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE

NCT ID: NCT03196882 Completed - Clinical trials for Risk of Hemoconcentration (Iron Levels >130g/L)

Effectiveness of Adaptation of the Dose of Iron Supplementation in Pregnancy on Maternal-child Health. (ECLIPSES)

(ECLIPSES)
Start date: July 10, 2013
Phase: Phase 4
Study type: Interventional

Currently, there is no consensus regarding iron supplementation dose that is most beneficial for maternal and offspring health during gestation. This deficit, or excess, of iron prejudices the mother-child wellbeing. Therefore the hypotheses are that an iron supplementation adapted to values of hemoglobin at the start of the pregnancy will would be more effective in preventing iron deficiency, without increasing the risk of hemoconcentration by the end of pregnancy. This would be helped optimize mother-child health status. The aims of the study are to determine the highest level of effectiveness of iron supplementation adapted to hemoglobin (Hb) levels in early pregnancy, which would be optimum for mother-child health. To accomplish this objective a Randomized Clinical Trial (RCT) triple-blinded was designed. The study is structured as a RCT with 2 strata, depending on the Hb levels before week 12 of gestation. Stratum 1: If Hb from 110 to 130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 80 mg/d. Stratum 2: If Hb >130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 20 mg/d. This study will be conducted in non-anemic pregnant women at early gestation stage, and their subsequent newborns. The data recollected to mothers will be: socio-economic data, clinical history, food item frequency, lifestyle and emotional state, and adherence to iron supplement prescription. In addition, biochemical measured will be Hemoglobin, serum ferritin, C reactive protein, cortisol, and alterations in the HFE gene (C282Y, H63D). In children, the data collected will be: ultrasound fetal biometry, anthropometric measurements, and temperament development Should conclusive outcomes be reached, the study would indicate the optimal iron supplementation dose required to promote maternal and infant health. These results would contribute towards developing guidelines for good clinical practice.

NCT ID: NCT03196297 Completed - Haemophilia A Clinical Trials

A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

explorerâ„¢5
Start date: August 16, 2017
Phase: Phase 2
Study type: Interventional

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors.

NCT ID: NCT03196284 Completed - Clinical trials for Congenital Bleeding Disorder

A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors

explorerâ„¢4
Start date: August 10, 2017
Phase: Phase 2
Study type: Interventional

This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.