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NCT ID: NCT03895099 Completed - Infertility Clinical Trials

New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors

RANDOS
Start date: September 4, 2020
Phase: Phase 3
Study type: Interventional

Oocyte donation is a cumbersome and demanding procedure, involving an injectable hormonal treatment for an average duration of 12 days, according to the protocols, 1 to several daily injections. The objective of this study is to show that treatments can be simplified without reducing the number of oocytes that have been punctured, by blocking the luteinizing hormone (LH) surge by using oral progesterone and by limiting the number of injections of gonadotropins using corifollitropin alpha, regardless of the start date of the pacing protocol during a natural cycle.

NCT ID: NCT03894969 Completed - Clinical trials for Respiratory Disorders

Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine

Start date: April 23, 2019
Phase: Phase 2
Study type: Interventional

This study will provide information regarding the sequential administration of two vaccines adjuvanted with AS01. The aim of this study is to understand immunogenicity and safety of NTHi-Mcat vaccine when administered sequentially after Shingrix vaccine and to compare to the immunogenicity of NTHi-Mcat vaccine administered alone. This study will also provide information regarding whether a specific time period is required between the administration of these two different vaccines containing the same adjuvant- AS01 components. The population of this study will include healthy smokers and ex-smokers of 50 to 80 years of age which will be used as a proxy for the COPD population.

NCT ID: NCT03894657 Completed - Cystic Fibrosis Clinical Trials

Validation of Respiratory Epithelial Functional Assessment to Predict Clinical Efficacy of Orkambi®.

PREDICT-CF
Start date: December 18, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate whether the correction of CFTR function by Lumacaftor/Ivacaftor in a patient-derived primary nasal cell model is a surrogate biomarker for respiratory improvement in Orkambi® treated patients.

NCT ID: NCT03893825 Completed - Schizophrenia Clinical Trials

A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia

SHINE
Start date: April 17, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse events, including serious adverse events. For new participants, the total duration of participant participation in the study is planned to be up to 80 weeks (including a screening period of up to 4 weeks, a 12-week oral conversion/stabilization stage [Stage 1], a 56-week double-blind maintenance stage [Stage 2], and a follow-up period [8 weeks]). For roll-over participants, the total duration of participant participation in the study is planned to be up to 64 weeks (including up to 56 weeks in the maintenance stage [Stage 2] and a follow-up period [8 weeks]). Participants who started Stage 2 who relapse or meet 1 or more of the withdrawal criteria should be invited to perform the Early Termination visit as soon as possible within 4 weeks of the last injection. Participants who withdraw from the study before completing the 56-week maintenance stage will have follow-up procedures and assessments performed at their follow-up visits. During the follow-up period, participants will be treated according to the investigator's judgment. All participants will be treated with active drug.

NCT ID: NCT03893279 Completed - Infectious Disease Clinical Trials

Perception of Smell and Taste During Antibiotic Treatment

OGUSTA
Start date: October 4, 2019
Phase:
Study type: Observational

Antibiotic use may be associated with effects on the perception of smell and taste. These effects are poorly known. The mechanisms can be very diverse, and the effect can be very variable depending on the type of antibiotic used, the dose, and the duration. The aim of this study is to analyze the perception of the taste and olfactory capacities of patients, during an antibiotic treatment.

NCT ID: NCT03893266 Completed - Clinical trials for Diabetes Mellitus, Type 1

Diabetic Patients Needs in Therapeutic Education About Work. TE-DIW (Therapeutic Education of DIabetic Working People)

ET-DIT
Start date: April 26, 2019
Phase:
Study type: Observational

Diabetes mellitus is an important disease around the world and the number of diabetic people increase every day. The type 1 diabetes often occurred in the youth and people have to learn to work with it and its complication. Conversely, diabetic people sometimes have trouble to manage their diabetes with working obligation. Actually, French therapeutic education don't teach how to reconcile diabetes and work. The study hypothesis is that type 1 diabetic people can be helped by therapeutic education in order to reconcile the management of their diabetes and their work. This study is a qualitative study. Interviews will help to find the needs of the type 1 diabetic patients to reconcile diabetes and work.

NCT ID: NCT03893240 Completed - Pompe Disease Clinical Trials

Neutralizing Antibody Seroprevalence Study With a Retrospective Component in Participants With Late-Onset Pompe Disease

Start date: June 12, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to obtain information pertaining to the occurrence of antibodies to investigational SPK-3006 capsid and GAA, GAA activity and GAA antigen levels in the usual care setting of Late-Onset Pompe Disease (LOPD) participants on an enzyme replacement regimen. Additionally, a careful evaluation of laboratory and functional testing in patients with LOPD may provide information to better understand the disease features and better drive the design of a future interventional investigational gene therapy trial. An understanding of the underlying status of liver and muscle health in individuals with LOPD may also inform best surveillance during the conduct of gene therapy trials.

NCT ID: NCT03892135 Completed - Clinical trials for Juvenile Idiopathic Arthritis

Representation and Medication Use in Juvenile Idiopathic Arthritis

RUMAJI
Start date: April 1, 2017
Phase:
Study type: Observational

According to the International League of Associations for Rheumatology classification, Juvenile Idiopathic Arthritis (JIA) comprises a heterogeneous group of arthritis of unknown cause and with onset before 16 years of age, characterized by joint inflammation lasting for 6 or more weeks. Few studies exist regarding the care experience of children affected by this rheumatic condition. On the other hand, methotrexate and biologics constitute the primary treatment for children with JIA. As with adults undergoing the same treatment, adherence is critical. Difficulties for children to take the drugs have been reported. Notwithstanding, if adherence promotion in pediatric chronic conditions has been the subject of recommendations with regard to care management, the investigators lack information to understand the grounds for adherence specifically in JIA. In order to understand and decipher the parent-child adherence mechanisms and practices, the RUMAJI study will be conducted. Indeed, improving the relational approach between children and their caregivers as well as unrestricted drug adherence involves researching and understanding how appropriation of the disease and treatment could be achieved.

NCT ID: NCT03890783 Completed - Clinical trials for Oropharyngeal Cancer

Functional Results of Soft Palate Free Flap Reconstruction

RECaVoLL
Start date: February 27, 2019
Phase:
Study type: Observational

The oropharynx is a complex anatomical structure necessary for nasal breathing, swallowing and phonation. The removal of oropharyngeal cancers can lead to sequelae, particularly in the case of resections affecting the soft palate. The main sequelae are represented by rhinolalia and swallowing disorders with nasal regurgitation. The treatment of oropharyngeal tumors is based on primary surgery or radiotherapy, but tumors of the soft palate are often treated by radiotherapy or radio-chemotherapy first. Surgery is often kept for relapses, because it is considered to lead to important sequelae. However, chemoradiotherapy of the oropharynx is also responsible for acute toxicities, and late sequelae can be frequent and important. Recent publications tend to show that primary surgery would give better survival rates compared to radiotherapy, particularly in advanced stages, including viro-induced cancers. In addition, primary surgery can reduce the dose of radiation delivered to the oropharynx and thus reduce its long-term toxicity. It is currently possible to reconstruct a loss of substance after surgery of oropharyngeal cancers, including the soft palate by using free flaps, limiting the postoperative sequelae usually observed without reconstruction. There is little data on reconstructions of the soft palate, their sequelae and their impact on the quality of life.

NCT ID: NCT03890627 Completed - Clinical trials for Pulmonary Hypertension

Thoracic Bio-reactance Measurement of Cardiac Output in Pulmonary Hypertension

PHREACT
Start date: May 21, 2019
Phase:
Study type: Observational

Pulmonary Hypertension (PH) is a rare disease characterized by an increase in pulmonary vascular resistance, leading to a progressive decline in cardiac output (CO).Since cardiac output is correlated with the prognosis of the disease, the conduct of a right heart catheterization (thermodilution measurement, reference technique) during the annual follow-up visit of patients in competences centres is recommended. In practice, it is not systematically performed because of it is invasive, with potential risk for the patient, and there is limited logistical capacity for its implementation. The estimation of cardiac output is thus often based on cardiac ultrasound but its measurement is potentially biased. Starling ™ SV is a non-invasive cardiac output monitor based on thoracic bio-reactance measurement. Several clinical studies have shown that cardiac output measured by bio-reactance is strongly correlated with the measurement obtained by catheterization in different indications. Rich et al. (2013) assessed bio-reactance specifically in 50 patients with Pulmonary Hypertension compared with thermodilution. The results showed that the measurement of cardiac output by bio-reactance was feasible in these patients, had a better accuracy than by catheterization, and was reliable for detecting changes in cardiac output after a vasodilatation test. The Starling ™ SV monitor could thus have a place in the follow-up of patients who are being treated for Pulmonary Hypertension. Since it is a rapid, non-invasive examination, it could be performed on an outpatient basis, especially as a first-line test to check the stability of the CO, thus avoiding the systematic use of right heart catheterization, which would then be reserved only to patients for whom the measurement by bio-reactance would show a decrease of cardiac output compared to the previous value. Before being able to propose this use in current practice, it is necessary to carry out a pilot study which will make it possible to explore the interest of bio-reactance in this situation.