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NCT ID: NCT03751475 Completed - Clinical trials for Severe Acute Malnutrition

Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Democratic Republic of Congo

OptiMA-DRC
Start date: July 22, 2019
Phase: N/A
Study type: Interventional

Acute malnutrition affects 51 million children under the age of 5 worldwide. Malnutrition contributes to nearly half of all child deaths each year, with the forms characterized by wasting or oedema (acute malnutrition) associated with the highest risk of death. Although acute malnutrition is a continuum condition, it is arbitrarily divided into severe and moderate acute malnutrition (SAM, MAM) which are managed separately, with programs overseen by different UN agencies, and using different protocols and products. Such separation complicates delivery of care, contributes to high default and low coverage, and creates confusion among caregivers. Often treatment is only available for SAM children resulting in lives lost and costly hospitalisation that could be averted if nutritional support were available earlier in the wasting process. If we are to reduce the health and mortality burden from malnutrition, the effectiveness and cost-effectiveness of current protocols need dramatic improvements. The dosage of Ready to Use Therapeutic Food (RUTF) for SAM (130-200 kcal/kg/d) has not changed since introduction of out-patient protocols in the mid-2000s. Children classified as SAM in these protocols are determined by three independent criteria: the presence of nutritional oedema or MUAC < 115 mm or weight-height Z score <-3. The RUTF dosage in these protocols is paradoxical in that the absolute amount of RUTF prescribed in the initial phases of treatment is often less than that given as the child nears recovery, because the number of packets in the weekly ration is determined by weight. However, rate of weight gain (g/kg/day) is highest in the first two weeks of treatment, and then plateaus - suggesting no benefit of increased RUTF amounts in the later phases of treatment. Progressive reduction seems to be a more rational use of RUTF. The Optimizing treatment for acute MAlnutrition (OptiMA) strategy consists in simplifying management of acute malnutrition through the use of a single anthropometric admission criterion (mid upper arm circumference [MUAC] < 125 mm or nutritional oedema) - one that best captures children's anthropometry related mortality risk- and by optimizing the use of RUTF by adapting doses to the nutritional recovery of the child. RUTF doses begin at 170 kcal/kg/d for the most severely wasted (MUAC < 115 mm or oedema) and reduce to 75 kcal/kg/d as oedema resolves and MUAC increases > 120 mm. The investigators hypothesize that this strategy could double the number of children in care compared to current SAM programs without substantially increasing the amount of RUTF or staffing required while maintaining a recovery rate in line with current programs. OptiMA may also improve coverage and reduce the need for hospitalization through early identification of malnourished children. The investigators propose to conduct a community-based non-inferiority clinical trial with individual randomization comparing the OptiMA strategy to the Democratic Republic of Congo standard nutritional protocol for SAM. Study children will be randomly assigned to the intervention arm or control arm - with children at MUAC < 125 mm or oedema eligible for RUTF in the intervention arm and those meeting current WHO SAM definition eligible in the control group. All participants will be followed for 9 months post-randomization to assess non-inferiority as defined by a composite of three endpoints : alive, acceptable nutritional status (MUAC ≥ 125 mm and WHZ >-3, no oedema) and no relapse to acute malnutrition for those who were treated with RUTF. The main secondary outcome will assess the non-inferiority of OptiMA RUTF dosing (170 kcal/kg/d) in children meeting current WHO SAM criteria compared to children with the same criteria in the control arm who will receive 130-200 kcal/kg/d.

NCT ID: NCT03751436 Completed - Clinical trials for Metastatic Prostate Carcinoma

Enzalutamide With Venetoclax in Treating Patients With Metastatic Castration Resistant Prostate Cancer

Start date: August 2, 2019
Phase: Phase 1
Study type: Interventional

This phase Ib/II trial studies the side effects and best dose of venetoclax when given together with enzalutamide and to see how well they work in treating patients with castration resistant prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, may lessen the amount of androgens made by the body. Venetoclax may target a special group of prostate cancer cells that is known to lead to resistance to treatment. Giving enzalutamide and venetoclax may work better in treating patients with castration resistant prostate cancer.

NCT ID: NCT03750721 Completed - Clinical trials for Bone and Joint Infection

Staphylococcal Acute Post-Operative PJI Treated With 'DAIR' And Impact Of Rifampin

IPASTAPH
Start date: April 1, 2018
Phase:
Study type: Observational

S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.

NCT ID: NCT03750591 Completed - Sciatica Clinical Trials

Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation

Start date: March 31, 2018
Phase:
Study type: Observational [Patient Registry]

Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation

NCT ID: NCT03750552 Completed - Clinical trials for Symptomatic Neurogenic Orthostatic Hypotension

Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

SEQUOIA
Start date: January 24, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.

NCT ID: NCT03750175 Completed - Clinical trials for Colorectal Cancer Metastatic

OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -

OPTIPAL-II
Start date: June 1, 2018
Phase:
Study type: Observational

The present study will investigate the feasibility and clinical value of using circulating tumor DNA as selection for anti-epidermal growth factor receptor treatment for metastatic colorectal cancer.

NCT ID: NCT03750058 Completed - Clinical trials for Cardiac Resynchronisation Therapy

Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

AXONE-Acute
Start date: August 8, 2018
Phase: N/A
Study type: Interventional

Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing

NCT ID: NCT03749473 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences

ENGAGE
Start date: January 14, 2019
Phase: N/A
Study type: Interventional

To use a randomized controlled trial to test the effectiveness of four goal-setting strategies within a gamification intervention to increase physical activity among adults at elevated risk for ASCVD.

NCT ID: NCT03749460 Completed - Clinical trials for Metastatic Malignant Neoplasm in the Bone

Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers

Start date: January 15, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and how well nivolumab and ipilimumab works when given together with stereotactic body radiation therapy (SBRT) in treating patients with salivary gland cancers. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving nivolumab and ipilimumab and SBRT may work better in treating patients with advanced salivary gland cancers.

NCT ID: NCT03748992 Completed - Clinical trials for Nontuberculous Mycobacterium Infection

A Proof of Concept Study of Inhaled Nitric Oxide for Adults With Pulmonary Non-Tuberculous Mycobacterial Infection

Start date: January 28, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of open-label exposure of gNO in patients with NTM lung disease. Subjects will receive the study drug by inhaling through a nasal mask. Subjects will be treated for 3 weeks (5 days per week) and followed monthly for 3 months.