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NCT ID: NCT04230434 Completed - Suicide Clinical Trials

Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior

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

The Safety Plan Intervention (SPI) has demonstrated to reduce suicide reattempts and to increase the ambulatory follow-up in american war veterans. This study evaluates the implementability and effectiveness in a significantly different population in a real world setting.

NCT ID: NCT04230239 Completed - Clinical trials for Newly Diagnosed Secondary or High Risk AML

Clinical Trial to Assess the Efficacy and Toxicity of Induction and Consolidation With CPX-351 for Patients Aged 60 to 75 Years With Secondary or High-risk Acute Myeloid Leukemia

LAMVYX
Start date: December 26, 2019
Phase: Phase 2
Study type: Interventional

This protocol corresponds to a prospective, multicentre, open label, phase II study designed to evaluate the efficacy of CPX-351 in elderly patients with secondary or high-risk AML. The clinical trial is divided into pre-treatment, treatment (induction and consolidation cycles) and follow-up periods and consists of a single arm group. Patients will be enrolled at diagnosis to follow the treatment arm. After that will start induction chemotherapy with CPX-351 regimen (14 days maximum screening period). Once a patient have been evaluated for response and recovered from major complications, he/she will start second course (consolidation 1), unless the bone marrow and peripheral blood assessment is showing less than a complete response, then a second induction may be offered. If a CR or CRi is obtained after the second induction course, patients will start the third course after a rest and recovery period. Patients aged between 60 and 65 years old are recommended to undergo an allo-SCT after first consolidation if they are considered fit for this procedure and they have a full matched related or unrelated donor. Patients aged between 65 and 70 years old can be proposed for an allo-SCT in CR/CRi if they have a composite HSCT co-morbidity index /age less than 4 and a suitable fully matched related donor. In patients over 70 years old, an allo-SCT in first CR should be avoided although the decision should be taken on an individual basis. Patients with CR/CRi who are not considered for an allo-SCT, will follow 6 maintenance cycles with modified courses of CPX-351 schedule. Patients showing unacceptable toxicity along all therapeutic phases that, in consideration of the investigator, will be prematurely discontinued. All patients will be followed-up for survival. The study will be analyzed on an intention to treat basis. Bone marrow and response assessments will be done after each induction and consolidation course, and every 3 months during the first 12 months after starting maintenance therapy. Patients will be followed-up for a minimum period of 1 year after the enrolment of the last patient. Additionally, after the end of the trial, patients will be followed-up for 2 years in order to verify survival and the evolution of the disease. Study design allows a maximum of 59 patients.

NCT ID: NCT04229836 Completed - Plaque Psoriasis Clinical Trials

Efficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)

TRIBUTE
Start date: December 17, 2019
Phase: Phase 4
Study type: Interventional

The main aim of the study is to evaluate the efficacy, safety and impact on the health-related quality of life (HRQoL) in participants with moderate-to-severe chronic plaque psoriasis who are treated with tildrakizumab 100 milligrams (mg).

NCT ID: NCT04228094 Completed - Clinical trials for Attention Deficit-hyperactivity Disorder

Assesment of TDApp1 an eHelath Tool to Make Therapeutic Recommendations for Patients With ADHD

Start date: August 10, 2020
Phase:
Study type: Observational

This is a 3-week open label, one group study to determine the agreement between the pharmacological treatment recommended by TDApp1 and the interventions recommended by relevant clinical practice guidelines.

NCT ID: NCT04226911 Completed - Obesity Clinical Trials

Sweeteners and Sweetness Enhancers: Prolonged Effects on Health, Obesity and Safety

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

The aim of this randomised controlled trial (RCT) is to investigate if prolonged consumption of sweetener and sweetness enhancers (S&SEs) within a healthy diet approach will improve weight loss maintenance and obesity related risk factors, and affect safety markers, compared to sugar. We hypothesize, that: - Prolonged use of S&SEs in beverages and food matrices will result in improved body weight control because S&SEs will increase palatability of the diet and thereby increase compliance to the recommendations for a healthy diet. - There will be no safety concerns using S&SEs in the long term. Overweight/obese adults and families where at least one adult (both gender) and one child (both gender) are overweight/obese will be recruited. The majority of measurements will only be conducted in the adult population and some measurement will only be done in sub-groups. The intervention will be performed in four countries: Denmark, Greece, Spain and the Netherlands. The goal is approximately 370 participants - 330 adults (18-65 years of age) and 40 children (6-12 years of age) - will be recruited for the study. All adult participants are first treated by a low energy diet (LED) for 2 months with the aim to reduce body weight (minimum 5% weight loss (WL)), whereas children are treated separately with a conventional weight maintenance (WM) diet, without a specific aim for absolute WL. The participants - both adults and families - are randomized into two different diet interventions for 10 months with or without inclusion of S&SEs products (foods and drinks). For adults, this period aims at preventing weight re-gain and for children maintaining body mass index (BMI)-for-age. The participants will receive food exchange lists and will be guided by dieticians. The randomization will be stratified by age, sex and BMI. Adults (not participating with children) belonging to the same household and all members of a family will be assigned the same intervention - the randomization will here solely be based on the oldest adult in the family/household. The adult participants are weighed at months 0, 0.5 and 1, and if needed at month 1.5. They are supervised during the WL period at months 0 and 1, and if needed at months 0.5 and 1.5, and throughout the WM period at months 2, 4, 6, 9 and 12. Children will follow a similar, but less strict time schedule (their participation is preferred but not required for all dietician meetings). The main assessment points are the clinical investigation days (CIDs) at month 0 (baseline, start of the WL period), 2 (end of the WL period/start of randomized intervention), 6 (6 months from baseline) and 12 (1 year from baseline).

NCT ID: NCT04226638 Completed - Clinical trials for Slipping Rib Syndrome

Slipping Rib Syndrome: A Clinical Entity to Consider in Chest Pain

Start date: February 2, 2017
Phase:
Study type: Observational

Slipping rib syndrome consists on false or floating ribs hypermobility, whose can force the ribs to come in contact with each other. The authors reported a fourteen case series presenting a slipping rib syndrome.

NCT ID: NCT04226274 Completed - McArdle Disease Clinical Trials

A Study of the Safety of REN001 in Patients With McArdle Disease

Start date: December 10, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess REN001 safety in subjects with McArdle Disease

NCT ID: NCT04225013 Completed - Kidney Injury Clinical Trials

Early Diagnosis as Strategy in Reducing the Incidence of Contrast-induced Nephropathy

Start date: June 1, 2015
Phase:
Study type: Observational

Renal damage due to contrast media (CM) administration is one of the main complications of cardiac intervention and is called contrast-induced nephropathy (CIN). Patients suffering from CIN have a high probability of developing acute renal failure. Today there is no treatment capable of reversing kidney damage, so the best strategy is prevention, by early diagnosis. In this regard, a line of research is currently being carried out focused on the identification of new markers capable of detecting susceptibility/predisposition to renal damage before the administration of a potentially nephrotoxic drug, even at doses that alone should not produce Kidney damage. This concept has been called predisposition to kidney damage. Taking into account all of the above, the objective of this work is to evaluate the ability of the new markers (previously identified in preclinical models) to detect the predisposition to the CIN before administering the CM.

NCT ID: NCT04222946 Completed - Healthy Clinical Trials

Stabilometry and Plantar Pressures Changes After Dry Needling in Flexor Digitoum Brevis.

Start date: January 7, 2020
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to check the effects of dry needling in the Flexor digitorum Brevis .

NCT ID: NCT04221724 Completed - Frailty Clinical Trials

Effects of Function-focused Multicomponent Physical Exercise Program. Interventional Single Group Study

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

The purpose of this research study is to determine whether a physical exercise program in nursing homes will maintain autonomy in activities of daily living, decrease vulnerability and improve physical, psychological and cognitive condition. An individualized and progressive multi-component physical exercise program focused on function has been designed to achieve this objective. Participant will engage in an exercise program for 6 months in their nursing homes, in two sessions per week of 45-60 minutes