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NCT ID: NCT03755128 Completed - Clinical trials for Erythroblastosis, Fetal

A Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn

Start date: January 16, 2019
Phase:
Study type: Observational

The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN).

NCT ID: NCT03754309 Completed - Dermatitis, Atopic Clinical Trials

A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis

Start date: December 13, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to investigate if KY1005 results in improvement of eczema when given to participants with moderate to severe disease. Side effects of KY1005 will also be explored.

NCT ID: NCT03753763 Completed - Clinical trials for Multiple System Atrophy

Safinamide for Multiple System Atrophy (MSA)

Start date: October 29, 2019
Phase: Phase 2
Study type: Interventional

The study is a placebo controlled study, with two parallel arms, in which participants will be randomly assigned in a 2:1 ratio to receive either active (200 mg safinamide) or placebo in a double blind manner. Study population is patients diagnosed, with possible or probable parkinsonian variant of Multiple System Atrophy who are on a stable treatment of levodopa

NCT ID: NCT03753581 Completed - Clinical trials for Electric Stimulation Therapy

Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People

Start date: October 31, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect on the healing of pressure ulcers in elderly people using a care protocol plus the application of microcurrent patches during 12 hours per day compared to the effect of the same protocol plus placebo electric stimulation.

NCT ID: NCT03752970 Completed - Crohn Disease Clinical Trials

A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease

Start date: February 5, 2019
Phase: Phase 2
Study type: Interventional

This is a study in adults with Crohn's Disease who also have fistulas near the anus. The study has 2 parts. The first part is to find out more about what causes the fistulas. In this part of the study, tissue samples are taken from patients. The second part of the study tests whether a medicine called spesolimab (BI 655130) helps patients with Crohn's Disease. Participants get study medication for 24 weeks. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets an intravenous drip that contains spesolimab every 4 weeks. The other group gets a placebo drip every 4 weeks. The placebo drip looks like the spesolimab drip, but contains no medicine. The doctors regularly examine fistulas of the participants. The results of the fistula examinations are compared between the groups. The doctors also check the general health of the patients.

NCT ID: NCT03752151 Completed - Clinical trials for Atrioventricular Conduction Block

Micra Atrial TRacking Using A Ventricular AccELerometer 2

MARVEL2
Start date: January 22, 2019
Phase: N/A
Study type: Interventional

The purpose of the Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2) study is to demonstrate safe and effective operation of the MARVEL 2 features for providing AV synchronous pacing in patients with normal sinus node function and AV block

NCT ID: NCT03751800 Completed - Menorrhagia Clinical Trials

A Study Run at Multiple Study Sites to Test Whether the SAMANTA Questionnaire That is Used to Diagnose Heavy Menstrual Bleeding (HMB), Can Also be Used to Assess Changes of Severity of HMB in Women With HMB Who Are Treated During 12 Months With a Chronic Hormonal Treatment

SAMIRA
Start date: December 12, 2018
Phase:
Study type: Observational

A study run at multiple study sites in Spain to test whether the SAMANTA questionnaire that is used to diagnose heavy menstrual bleeding (HMB), can also be used to assess changes of severity of HMB in women with HMB who are treated during 12 months with a chronic hormonal treatment. Patients that are treated with chronic hormonal treatment as Levonorgestrel (trade name Mirena) or with a combination of estradiol valerate and dienogest (trade name Qlaira) or with Medroxyprogesterone acetate (trade name Progevera) and any new hormonal treatment marketed in Spain that has the indication for HMB in routine gynaecological practice are observed for 12 months in this study or for a shorter period in time in case of withdrawal. The study aims also to describe the overall satisfaction of women with their chronic hormonal treatment for HMB and how the women think their menstrual bleeding has changed. In addition the study aims to describe the changes of the score that is derived from the SAMANTA questionnaire in relation to Quality of Life. Quality of Life is measured with the SF36v2 questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.

NCT ID: NCT03750786 Completed - Colo-rectal Cancer Clinical Trials

A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

AGENT
Start date: December 18, 2018
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

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: NCT03749291 Completed - Clinical trials for Microbial Colonization

Motivational Intervention on the Gut Microbiota of Obese Children

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

Animal models and studies on small samples of obese adults have shown that gut microbial diversity and certain types of bacteria could predict the efficacy of the dietetic treatment to improve body mass index (BMI) and the components of metabolic syndrome (MetS). Gut microbiota could distinguish the obese with metabolic syndrome patient than that metabolically healthy. Dietetic therapy could induce changes in the microbiota that could lead to improvement of BMI and the components of the MetS. The aim of MICROBEkids is to test whether the motivational intervention a motivational intervention (OBEMAT2.0) (PI15/00970) is more effective than the conventional intervention to increase the gut microbial diversity and, as a consequence, to improve BMI and MetS components. The role of gut microbiota (through modulation of the short chain fatty acids) will be analyzed as cardiovascular risk factor and as predictor of treatment success. These objectives will be achieved through a clustered clinical trial design with an intervention group that will receive a motivational therapy compared to a control group that will receive a conventional intervention, both during 12 months. The study sample are 319 children (n= 167 in the intervention group) that were enrolled in the clinical trial OBEMAT2.0 (PI15/00970), have had a comprehensive clinical assessment before the intervention (ages 8 to 14) and after 12 months (+3) of therapy (ages 9 to 15) and furthermore have participated in a biological samples collection for the investigation on childhood obesity (COLOBEPED, reference C.0004585).