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NCT ID: NCT04771910 Recruiting - Atopic Dermatitis Clinical Trials

Study of the Skin Microbiome and the Potential of a Topical Probiotic Cream for Atopic Dermatitis

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The skin microbiome of atopic dermatitis patients and healthy volunteers will be studies by collecting and analysing skin swabs on different timepoint. Additional, effort will be made to isolate and characterize Lactobacillus spp. and other beneficial micro-organisms on the skin. Second aim of this study is to evaluate a topical probiotic cream in atopic dermatitis treatment. A double-blind placebo-controlled intervention study will be performed in parallel with the skin microbiome analysis. Both clinical effect on the symptoms of atopic dermatitis and effect on the skin microbiome and survival of beneficial bacteria on the skin will be evaluated.

NCT ID: NCT04770337 Recruiting - Epilepsy Clinical Trials

Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

NCT ID: NCT04769895 Recruiting - Clinical trials for Steroid Refractory GVHD

MaaT013 as Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients

ARES
Start date: March 25, 2022
Phase: Phase 3
Study type: Interventional

MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as salvage therapy in steroid and JAK inhibitors-resistant GI-aGvHD patients. Given the absence of an approved 3rd line strategy or 2nd line strategy in ruxolitinib intolerant patients and the extremely poor prognosis of these patients, who are mostly left with no viable therapeutic option, a single-arm open-label design was proposed.

NCT ID: NCT04769037 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity

SINT1A
Start date: April 22, 2021
Phase: N/A
Study type: Interventional

Investigator initiated, randomised, placebo-controlled, double-blind, multi-centre primary intervention study to assess whether daily administration of B. infantis EVC001 from age 7 days to 6 weeks (+14 days) until age 12 months (+ 14 days) to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.

NCT ID: NCT04768972 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)

Start date: June 14, 2021
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS).

NCT ID: NCT04766866 Recruiting - Preeclampsia Clinical Trials

sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.

PE37
Start date: March 2, 2021
Phase: N/A
Study type: Interventional

- Preeclampsia (PE) affects ~5% of pregnancies. Although improved obstetrical care has significantly diminished associated maternal mortality, PE remains a leading cause of maternal morbidity and mortality in the world. - Term PE accounts for 70% of all PE and a large proportion of maternal-fetal morbidity related with this condition. Prediction and prevention of term PE remains unsolved. - Previously proposed approaches are based on combined screening and/or prophylactic drugs, but these policies are unlikely to be implementable in many world settings. - Recent evidence shows that sFlt1-PlGF ratio at 35-37w predicts term PE with 80% detection rate. - Likewise, recent studies demonstrate that induction of labor (IOL) from 37w is safe. - The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-37w followed by IOL from 37w would reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes. - The investigators propose a randomized clinical trial to evaluate the impact of a screening of term PE with sFlt-1/PlGF ratio in asymptomatic nulliparous women at 35-37w. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cutoff of >90th centile will be used to define high risk of PE and offer IOL from 37w. - If successful, the results of this trial will provide evidence to support a simple universal screening strategy reducing the prevalence of term PE, which could be applicable in most healthcare settings and have enormous implications on perinatal outcomes and public health policies worldwide.

NCT ID: NCT04758936 Recruiting - Critical Illness Clinical Trials

Clonidine vs. Dexmedetomidine in Agitated Delirium in Intensive Care Patients

Clodex
Start date: February 1, 2021
Phase: Phase 4
Study type: Interventional

Delirium is one of the most common manifestations of cerebral dysfunction in severely ill patients. The international guidelines for the prevention of delirium in intensive care recommend the daily application of environmental, behavioral and pharmacological strategies. In the case of the agitated form of delirium, experts recommend the use of low-dose neuroleptics and α-2 agonists to control psychotic manifestations rather than traditional sedatives (mainly benzodiazepines) that can clearly aggravate delirium. Currently, two pharmacological α-2 agonists, clonidine (Catapressan®, Boehringer Ingelheim) and dexmedetomidine (Dexdor®, Orion Corporation), are marketed and commonly used in intensive care for their sedative, anxiolytic and analgesic properties. To our knowledge, no studies have compared the effects of clonidine and dexmedetomidine in agitated delirium in intensive care patients. Therefore, our goal is to compare the safety of clonidine and dexmedetomidine (in terms of bradycardia and / or hypotension) in addition to standard treatment in the context of agitated delirium in intensive care patients.

NCT ID: NCT04758650 Recruiting - Cancer Clinical Trials

Study of 68GaNOTA-Anti-MMR-VHH2 in Oncological Lesions, Cardiovascular Atherosclerosis, Syndrome With Abnormal Immune Activation and sarcoïdosis

MITRAS
Start date: January 26, 2021
Phase: Phase 2
Study type: Interventional

Phase II study to evaluate the clinical potential of 68GaNOTA-anti-MMR-VHH2 for in vivo imaging of Macrophage Mannose Receptor (MMR)-expressing Macrophages by means of Positron Emission Tomography (PET) in patients with oncological lesions in need of non-surgical therapy, patients with cardiovascular atherosclerosis, syndrome with abnormal immune activation and sarcoïdosis.

NCT ID: NCT04756791 Recruiting - Clinical trials for Mastectomy; Lymphedema

Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery

SAPLIA
Start date: June 16, 2021
Phase: Phase 4
Study type: Interventional

To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.

NCT ID: NCT04755504 Recruiting - Sleep Clinical Trials

The Development of an Algorithm to Detect Sleep Structure With a Wearable EEG Monitor in an Elderly Population

Start date: January 21, 2021
Phase: N/A
Study type: Interventional

To evaluate whether it is able to perform sleep staging with EEG data recorded from 2 electrodes behind each ear.