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NCT ID: NCT04194567 Completed - Iron-deficiency Clinical Trials

Effect of Polyphenols on Iron Absorption From Finger Millet

Start date: November 4, 2019
Phase: N/A
Study type: Interventional

In India, one of the fast growing countries, 53% of all women have anaemia as per the National Family Health Survey. A recently published study on the burden of disease in India concluded that the burden of Iron deficiency anaemia (IDA) is 3 times higher than the average globally for other geographies at a similar level of development, and that women are disproportionately affected. Finger Millet (Eleusine coracana), more commonly known as Ragi, is a type of a millet crop grown in India, is considerably rich in minerals and its micronutrient density is higher than that of the world's major cereal grains: rice and wheat. Ragi also contains different antinutrients such as phytates and polyphenols, which have been known to have an inhibiting effect on the absorption of iron. On an average, white finger millet contains 0.04-0.09% polyphenols and brown varieties have 0.08-3.47%. The dark variety of ragi is the most widely consumed type. The white ragi is the lesser consumed type. However, the levels of polyphenols, which inhibit the absorption of iron, are ten times lower in the white ragi as compared to the dark ragi. Thus, it is important to evaluate the extent of inhibition of the polyphenols on the iron absorption. This information would be beneficial for policy making and promotion of cultivation of the type of ragi that could be most effective for the consumers

NCT ID: NCT04194281 Completed - Clinical trials for Perinatal Brain Injury

Feasibility of Action Observation Training [AOT] in Infants After Unilateral Brain Lesion

Start date: May 30, 2020
Phase: N/A
Study type: Interventional

The study examines whether infants with a perinatal unilateral brain lesion can perform an "Action Observation Training" [AOT] at the age of 9-12 months . AOT is the targeted and concentrated observation of movements and actions to learn new motor skills. In adults with hemiplegia after a stroke and in older children with hemiplegia, AOT can lead to an improvement in the functions of the affected hand/arm. Infants with early unilateral brain damage are at increased risk of developing a hemiplegia and thus impaired upper limb function. There is little known about treatment options to promote arm and hand skills in early childhood and their effectiveness. In particular, there is a lack of knowledge whether AOT could also be used in infants. It is known that even in infants at an early age brain activity can be measured while they are observing movements and infants learn a lot about observing and imitating. Knowledge about the measurement of manual skills is also reduced. So far, tests have been used to observe and evaluate how infants use their hands when playing (e.g. Mini-Assisting Hand Assessment). The aim of this study is to investigate whether measurements with motion sensors can also be used in infants. In the pre-post study, about 5 to 10 toddlers will be examined. During four weeks, the parents should give the child 20 minutes of AOT per day at home. A therapy diary will be completed for this purpose. During six weeks, the parents will use movement sensors on two days a week for the upper limb of the infants. Finally, three questionnaires about the AOT and the motion sensors will be completed by the parents.

NCT ID: NCT04194255 Completed - Iron-deficiency Clinical Trials

The Effect of Different Prebiotics on Iron Absorption From High Dose Iron Supplements

Start date: July 20, 2020
Phase: N/A
Study type: Interventional

Iron deficiency (ID) remains the most common global nutrient deficiency, with young women at high risk. Iron supplements are first line treatment for ID but absorption is often low. Dietary components that could increase iron absorption would be valuable. Prebiotics are among the potential enhancers of non-heme iron absorption. Galacto-oligosaccharides (GOS), fructo-oligosaccharides and acacia gum are safe and widely-used prebiotics. To our knowledge, no studies have assessed the effect of acacia gum on iron absorption in human or animal models. Evidence exists about the enhancement of iron absorption when given in combination with FOS in rats. However, an iron stable isotope study in infants reported that 7.5 g of GOS improved iron absorption from 5 mg iron from a mixture of ferrous fumarate and sodium iron EDTA. In a recent iron absorption study in adult women with low iron stores in our lab we found that 15 g of GOS given with FeFum (14 mg of elemental iron) acutely increased iron absorption when given with water (+61%) and a meal (+28%). For prevention of anemia among non-pregnant women, the WHO recommends intermittent (once, twice or three times a week) oral iron supplementation with 60 mg of elemental iron. This has been shown to be effective, safe and acceptable for improving hemoglobin concentrations in women and lowering their risk of anemia. If GOS improves iron absorption from a higher dose of iron, and if FOS and acacia gum might also enhance iron absorption from FeFum is unclear. With this study we therefore aim to investigate if consumption of a single oral dose of 15 g GOS, FOS or acacia gum increase iron absorption from single 100 mg oral iron doses, a common amount found in supplements on the market for treatment of iron deficiency, given as ferrous fumarate in otherwise healthy iron depleted women.

NCT ID: NCT04191304 Recruiting - Clinical trials for Hypereosinophilic Syndrome

A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

NATRON
Start date: July 20, 2020
Phase: Phase 3
Study type: Interventional

This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to their prior stable HES background therapy, and an open-label extension (OLE) period, during which all patients will receive benralizumab. Patients will continue to be recruited until approximately 38 patients have had their first HES worsening/flare during the DB treatment period at which point the data cut-off for the primary database lock (DBL) will occur. Treatment allocation will remain blinded until the primary DBL. After the study is unblinded for the primary analysis, patients and investigators will remain blinded to patients' individual treatment allocations until after the final patient completes the DB treatment period. The primary analysis will only include data from the DB treatment period of the study. A follow-up analysis will be performed once all patients have the opportunity to complete the 24-week DB treatment period. A patient must complete the 24-week DB treatment period on investigational product (IP) to be eligible to enter the OLE treatment period. The final DBL will occur after the last patient completes the OLE.

NCT ID: NCT04191096 Active, not recruiting - Clinical trials for Metastatic Hormone-Sensitive Prostate Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)

Start date: February 12, 2020
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment until meeting protocol-specified discontinuation criteria if deriving clinical benefit. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.

NCT ID: NCT04190602 Recruiting - Clinical trials for Mitral Regurgitation

Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

AcChord
Start date: February 9, 2020
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.

NCT ID: NCT04190251 Completed - Clinical trials for Diabetes Mellitus, Type 2

PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program

PANDIA_IRIS
Start date: April 14, 2016
Phase: N/A
Study type: Interventional

Monocentric, randomised, controlled and open study. Subjects will be included prospectively and consecutively and randomly assigned into two groups. Intervention group A will benefit a medication adherence support program during 12 months while intervention group B during 6 months only. Adherence will be monitored using an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd.) during 24 months. At each pharmacy visit, the pharmacist will conduct a semi-structured interview in 15 minutes based on Fisher's sociocognitive model with the patients. A summary of the interview and the adherence graph will be send to the patient' health professionals.

NCT ID: NCT04189250 Recruiting - Hemoglobins Clinical Trials

Comparison of the Automatized and the Optimized Carbon Monoxid Rebreathing Protocol

Start date: January 20, 2020
Phase: N/A
Study type: Interventional

The aim of this study is the comparison of two measurement protocols determining hemoglobin mass with two different blood sampling strategies.Both protocols are based on the principle of the carbonmonoxid (CO) rebreathing method. During this measurement, CO is inhaled for a specific time period by the subject in a closed circuit and it is used as a marker to tag circulating hemoglobin.

NCT ID: NCT04188444 Completed - Sterility, Female Clinical Trials

Prothrombotic Biomarkers and Ovarian Stimulation

HEMOSTIM
Start date: March 1, 2017
Phase:
Study type: Observational

The aim of this study is to assess the impact of different protocols used for ovarian stimulation during in vitro fertilization procedures (IVF) on prothrombotic biomarkers (blood coagulation markers associated with thromboembolic events) in the units of reproductive medicine in two university hospitals (HUG, Geneva and CHUV, Lausanne).

NCT ID: NCT04188431 Terminated - Pain, Postoperative Clinical Trials

Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children

Blueberry
Start date: November 1, 2020
Phase: Phase 4
Study type: Interventional

Tonsillectomy is one of the most frequently performed surgical interventions in children. However, it is associated with a high incidence of PostOperative Nausea and Vomiting (PONV), severe pain and haemorrhage. There is strong evidence on the efficacy of Dexamethasone in reducing the incidence of PONV and pain after tonsillectomy, which led to consider this drug as a first line treatment in routine anaesthesia practice in such surgical setting. However, in the last decade, there have been arguments about the potential role of Dexamethasone in increasing the risk of postoperative bleeding in children and studies addressing the haemorrhage risk following administration of Dexamethasone for tonsillectomy are inconclusive.Thus, this study is aimed at providing evidence for the safety profile of Dexamethasone with regard to the risk of post-tonsillectomy bleeding in children when administered as a single intraoperative dose.