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NCT ID: NCT03891446 Enrolling by invitation - Ocular Hypertension Clinical Trials

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Maia
Start date: March 27, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

NCT ID: NCT03789825 Enrolling by invitation - Liver Diseases Clinical Trials

Population-based Study in Screening for Liver Fibrosis

LiverScreen
Start date: May 1, 2018
Phase:
Study type: Observational

Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography

NCT ID: NCT03767101 Enrolling by invitation - Mental Disorders Clinical Trials

Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy

PACIfIC
Start date: November 2, 2018
Phase: N/A
Study type: Interventional

Background: Research findings suggested that people with mental disorders show a dysfunctional upregulation of negative affect (NA) but at the same time a dysfunctional downregulation of positive affect (PA) as distinct processes. Nevertheless, established treatment approaches focus on the modification of problems and negative affect only. Experimental paradigms with healthy and subclinical populations showed that PA inductions lead to higher flexibility in information processing, cognitive appraisal and action tendencies. Higher amounts of PA were associated with more personal resources, higher psychological resilience and subjective well-being. Preliminary evidence indicated that a focus on positive and functional aspects in the life of patients lead to better treatment sessions and outcome. However, the role of PA for the process in cognitive behavioral therapy remains unclear. Method/Design: In regard to this we developed the PACIfIC-study, serving the following objectives: (1) to explore the trajectories of PA and NA and their association with relevant process variables in an early phase of CBT treatment. (2) To develop and test the feasibility of a brief and easily implementable intervention to promote PA in psychotherapy sessions. (3) To analyze the impact of this intervention on the therapeutic process between and within CBT sessions and intermediate outcomes. The study includes a randomized contolled, longitudinal design in an outpatient research and treatment center. Both a process and an intervention analysis will be conducted. In the process analysis, we will examine the course of PA and NA in the first twelve sessions of CBT treatments. In the intervention analysis, we will examine the effects of a six-minute positive mental imagery intervention during an early phase of psychotherapy. The aim of this micro-intervention is to foster patients' in-session PA, which may lead to increased levels of subjective resources, resilience, and self-esteem (theory-driven outcome) as well as improvements in psychopathology and working alliance (secondary outcome). Discussion: The study results may have important theoretical and practical implications on the use of PA in psychotherapeutic treatment. Furthermore an economic implementation of strengths-oriented interventions in psychotherapy practice may be initiated.

NCT ID: NCT03745924 Enrolling by invitation - Haemophilia B Clinical Trials

A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN

Start date: April 1, 2019
Phase:
Study type: Observational

This study will collect information on side effects and how well Refixia/REBINYN works during long-term treatment (prophylaxis) in males with haemophilia B. While taking part in this study, participants will receive the same treatment as given to them by their study doctor. All visits at the clinic are done in the same way as the participants are used to. During visits at the clinic, participants might be asked for some relevant tests if considered useful by their study doctor. During the visits, the participants study doctor might ask if the participants had any side effects since their last study visit. The participants will be asked to note down the number of bleeds and the treatment of their bleeds as well as their regular prophylaxis. During the visits to the clinic, the participants will be asked to answer some questionnaires about their quality of life and their ability to be physically active. The participant's participation in the study will last for 4-9 years, depending on when they join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.

NCT ID: NCT03683186 Enrolling by invitation - Hypertension Clinical Trials

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Start date: September 23, 2019
Phase: Phase 3
Study type: Interventional

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

NCT ID: NCT03604198 Enrolling by invitation - Cushing Syndrome Clinical Trials

Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

Start date: May 7, 2018
Phase: Phase 2
Study type: Interventional

This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

NCT ID: NCT03584165 Enrolling by invitation - Choroideremia Clinical Trials

Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis Pigmentosa

SOLSTICE
Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate the long-term safety and efficacy of a sub-retinal injection of BIIB111 in participants with Choroideremia (CHM) who have been previously treated with BIIB111 and who have exited an antecedent study; these treated participants will be compared with untreated control participants who have exited the STAR (NCT03496012) study and BIIB112 in participants with X-linked retinitis pigmentosa (XLRP) who have been previously treated with BIIB112 and who have exited an antecedent study.

NCT ID: NCT03576573 Enrolling by invitation - Joint Disease Clinical Trials

Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components

Start date: March 27, 2019
Phase:
Study type: Observational

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

NCT ID: NCT03568318 Enrolling by invitation - Atopic Dermatitis Clinical Trials

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

AD Up
Start date: August 9, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT03482817 Enrolling by invitation - Clinical trials for Drug Interaction Study

Drug Cocktail Interaction Study of St. John's Wort Dry Extract Ze 117

Start date: February 5, 2018
Phase: Phase 1
Study type: Interventional

This Study evaluates the Effect of St. John's Wort dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers.