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NCT ID: NCT04532853 Completed - COPD Clinical Trials

Optimizing Maintenance Therapy in COPD Patients

PIFOTAL
Start date: October 21, 2020
Phase:
Study type: Observational

Background: Effectiveness of maintenance therapy for COPD with Dry Powder Inhalers (DPIs) requires an optimal Peak Inspiratory Flow Rate (PIFR), a proper inhalation technique and adequate medication adherence from patients. Recent studies have suggested that patients with reduced peak inspiratory flow may have worse COPD-related symptom burden and increased risk of COPD-related hospitalizations. However, in primary care, little is known about how many COPD patients have suboptimal PIFR. Furthermore, there is a paucity of knowledge concerning the associations of PIFR, inhalation technique and medication adherence with the effectiveness of maintenance therapy. Objective: To examine associations of PIFR, inhalation technique, and medication adherence with health status and disease, exacerbations, and healthcare resource utilization in patients with COPD receiving maintenance treatment with dry powder inhalers. Study design: Cross-sectional observational study in five European countries*. Study population: COPD patients aged 40 years or older who have received COPD maintenance therapy through DPIs in the past 3 months or longer. Main study parameters: Health status as measured with the Clinical COPD Questionnaire (CCQ), COPD Assessment Test (CAT), number of exacerbations, an assessment of PIFR, inhalation technique errors, medication adherence, healthcare resource utilization (HCRU), medication use and demographic and clinical covariates. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No significant burden from participating is expected. Risk of participating is deemed negligible. In addition, patients may benefit from participating. Specifically, patients who manifest inhalation errors, will receive a tailored inhalation instruction to remediate their inhalation errors. The impact of this instruction will not be evaluated in any way, therefore it should not be seen as an intervention. * If the preplanned number of patients cannot be included also because of national outbreaks of SARS-COV-2 resulting in travel restrictions, participation will be sought from researchers from three other European countries

NCT ID: NCT04530344 Completed - Vitiligo Clinical Trials

Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

Start date: September 24, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.

NCT ID: NCT04529850 Completed - Clinical trials for Head and Neck Cancer

Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer

Start date: June 30, 2020
Phase: Phase 2
Study type: Interventional

GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)

NCT ID: NCT04529317 Completed - Type 2 Diabetes Clinical Trials

Beneficial Effects of Quinoa (Chenopodium Quinoa Willd) in the Prevention of Type 2 Diabetes Mellitus

Start date: May 2016
Phase: N/A
Study type: Interventional

Quinoa is a pseudo-cereal and has potential health benefits and exceptional nutritional value. It is a food rich in proteins of high biological value, in unsaturated fats and fiber, it is also a grain low in carbohydrates and with a low glycemic index. Concretely, quinoa could produce a benefit on postprandial glycemia that would result in lower type 2 diabetes (T2D) incidence. A cross-over design pilot clinical study with a nutritional intervention for 8 weeks were performed: 4 weeks on a regular diet (RD) and 4 weeks on a quinoa diet (QD). Nine subjects aged ≥65 years with prediabetes were monitored during the first 4 weeks of RD with daily dietary records and FreeStyle Libre®. Subsequently, participants started the DQ where quinoa and 100% quinoa-based products replaced foods rich in complex carbohydrates that they regularly consumed by the first 4 weeks of DR. The glycemic measurements recorded by the sensors were considered as functions of time and the effects of nutrients consumed at the intended time period were analyzed by means of function on scalar regression (fosr) model.

NCT ID: NCT04527627 Completed - Depression Clinical Trials

Nursing Intervention in the Patient Being Discharged From the Intensive Care Unit

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Background: Psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder (PTSD), are common among critical disease survivors. Interventions aimed to decrease ICU impact on patient mental well-being are needed. Methods/Design: The study will evaluate an educational nursing intervention addressed to ease the transition during ICU discharge by empowering the patient. A quantitative design will be used to measure the effectiveness of the nursing intervention through an experimental pre-test/post-test with control group design. Participants will consist of patients from three critical care units from three different hospitals. Data will be obtained from Hospital Anxiety and Depression Scale (HADS). Data will be analysed through descriptive and inferential statistics. Discussion: This study will help to develop and implement an intervention to help patients lessen anxiety and depression associated to their transition from ICU to the general ward.

NCT ID: NCT04527107 Completed - Diabetes Mellitus Clinical Trials

A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

KALAHARI
Start date: July 31, 2020
Phase: Phase 2
Study type: Interventional

Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

NCT ID: NCT04526704 Completed - Clinical trials for Tenosynovial Giant Cell Tumor

Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib

PLX3397
Start date: October 20, 2020
Phase: Phase 4
Study type: Interventional

This study is designed to evaluate the discontinuation/re-treatment of pexidartinib therapy in previously treated participants with tenosynovial giant cell tumor (TGCT).

NCT ID: NCT04526535 Completed - Heart Failure Clinical Trials

Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI)

LUS-AMI
Start date: June 15, 2020
Phase:
Study type: Observational

The purpose of this study is to asses the prognostic value of lung ultrasound in patients with ST-segment elevation acute myocardial infarction.

NCT ID: NCT04525443 Completed - COVID-19 Clinical Trials

Endothelial Function and COVID-19

Start date: June 3, 2020
Phase:
Study type: Observational

The present study aims to investigate the endothelial vasodilator function in patients with COVID-19

NCT ID: NCT04524455 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL

Start date: October 2, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.